Clinical trials provide patients the opportunity to receive drugs or therapies years before they’re approved by the FDA. At West Cancer Center, our patients have advanced access to the therapies of tomorrow – today

Stage
Phase
Status
Bladder: Metastatic: Phase I: 2nd Line: Immunotherapy Combination: "B-701-U22"

A multi-center, single-arm, open-label phase 1b study of a novel FGFR2 inhibitor (B-701) combined with pembrolizumab in subjects with locally advanced or metastatic urothelial carcinoma who have progresseed following platinum-based chemotherapy

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder, Urothelial, Metastatic Bladder Cancer, MBC, Transitional Cell Carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

B-701, pembrolizumab

Drug Class

FGFR3 inhibitor, PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Bioclin Therapeutics, Inc.

Key Eligibility Criteria Details
  • Have histologically confirmed locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis.
  • Have relapsed after or refractory disease to at least one prior line of systemic chemotherapy for locally advanced or metastatic disease (at least one cycle). At least one regimen should have included a platinum agent unless contraindicated. A regimen of neoadjuvant or adjuvant chemotherapy will be counted as first line chemotherapy if the patient progressed within 12 months of the last dose.
  • Have measurable disease according to RECIST v1.1.
  • Available archival tumor tissue that was obtained at the time or after the subject was found to have muscle invasive or metastatic disease, and is of suitable quality and quantity
  • No history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan
  • No previous checkpoint inhibitor or FGFR inhibitor.
  • No History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months.
BLADDER: Metastatic: PHASE 1: PD-1 Naive: 2nd Line: "PROPEL BLADDER"

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder, Transitional Cell Carcinoma, TCC, Urothelial Carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd (1st if patient refuses platinum-based therapy)

Investigational Agent

NKTR-214, atezolizumab

Drug Class

pegylated IL-2, PD-L1 inhibitor

PI

Dan Vaena, MD

Sponsor

Nektar Therapeutics

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced or metastatic urothelial carcinoma
  • ECOG PS 0-1
  • Measurable disease per RECIST 1.1
  • No prior receipt of immunotherapy with immunomodulators (eg. PD-1 inhibitors, CTLA-4 inhibitors, IDO inhibitors)
  • Either;
    • No more than 1 prior line of platinum-containing therapy with disease progression on or following this therapy OR
    • Patient refuses standard of care therapy in the 1st line
  •  No history of or active autoimmune disease (exceptions include Hashimoto's thyroiditis, Graves' disease, TIDDM, or Med Monitor approval)
BREAST: Primary Treatment; T<1.5cm; Age>65; ER/PR+ HER2-: "Ice3"

Cryoablation of low risk breast cancer less than 1.5 cm: An evaluation of local recurrence (Ice-3 trial)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer, early

Stage

Stage 1

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Ice-Sense3TM

Drug Class

Cryoablative device

PI

Richard Fine, MD, FACS

Sponsor

IceCure Medical

Key Eligibility Criteria Details

 

  • Age >65
  • Tumor size <1.5cm in greatest dimension
  • Unifocal Primary DiseaseInvasive Ductal Carcinoma
  • ER+, PR+ HER2-
  • Ki-67<14%
  • Nottingham Grade 1-2
  • No microinvasion or extensive intraductal component
  • No multi-focal calcifications
  • No prior or concurrent neoadjuvant therapy
  • No en bloc open biopsy or lumpectomy on tissue specimen
BREAST: NEOADJUVANT: TRIPLE NEGATIVE: "KEYNOTE 522"

A phase III, randomized, double-blind study to evaluate pembrolizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy for triple negative breast cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Key Eligibility Criteria Details
  • Previously untreated locally advanced non-metastatic TNBC definedn as one of the following TNM classifications:
    • T1c, N1-N2
    • T2, N0-N2
    • T3, N0-N2
    • T4a-d, N0-N2
  • ECOG Performance Status 0-1
  • No history of other malignancy within 5 years except cervical CIS, or non-melanoma skin cancer
  • No prior therapy with anti-PD-1
  • No active autoimmune disease that required systemic treatment in past 2 years
BREAST: Neoadjuvant: Phase 1: HER2+: Immunotherapy combination: “GO29831- Neoadjuvant”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Breast Neoadjuvant, HER2+

Stage

Stage 2

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

PI

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Key Eligibility Criteria Details
  • Men or women

  • Primary tumor size >2cm

  • Stage at presentation cT2-cT4, cN0-cN3, cM0

  • HER2 positive disease (ISH positive and/or 3+ by IHC)

  • HLA-A2 positive (by central laboratory)

  • ECOG PS 0-2

  • Adequate lab tests

  • Baseline LVEF >50% by ECHO or MUGA

  • No prior systemic therapy for treatment or prevention of breast cancer

  • No history of DCIS unless >5 years prior to current diagnosis

  • No Grade 2 or higher peripheral neuropathy

  • No history of autoimmune disease, need for current immunosuppressants

  • No HBV/HCV/HIV

BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; axillary dissection vs XRT; “Alliance-011202”

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

N/A

Drug Class

N/A

PI

Richard Fine, MD

Sponsor

Alliance for Clinical Trials in Oncology

Key Eligibility Criteria Details
  • Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
  • No inflammatory breast cancer
  • No other malignancy within 5 years
  • Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
  • Must have documented ER/PR/HER2 status before neoadjuvant therapy
  • Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
  • Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
  • HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
  • Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
  • No neoadjuvant endocrine or radiation therapy
  • No history of prior breast cancer
  • ECOG PS 0-1
  • Must complete surgery within 56 days of finish of neoadjuvant therapy
  • At least 1 sentinel lymph node identified intra-operatively with at least micromets
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"
A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Key Eligibility Criteria Details
  • Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)

  • Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

  • HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)

  • Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen

  • For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization

  • Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

  • At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer

  • ECOG PS 0-1

BREAST: Adjuvant: ER/PR+: HER2-; "e3"
Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, early breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Key Eligibility Criteria Details
High risk early breast cancer as defined as follows:
-Post adjuvant chemo withTumor >2cm, N0, Oncotype Dx >25 or
-Post adjuvantchemo with 1-3 positive nodes, OncDx >25 or
-Post adjuvant chemo with >3 positive nodes or
-Post neoadjuvant chemo with >3 positive nodes
HER2 negative, ER/PR positive
Completed standard neoadjuvant or adjuvant taxane or anthracycline therapy
No prior receipt of MTOR inhibitors
ECOG PS 0-2
Fasting cholesterol <300, TG <2.5x ULN
HIV positive allowed if controlled CD4 count and NOT on ART
BREAST: Metastatic: Phase 1: Immunotherapy combination: “GO29831- Metastatic”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic HER2 positive breast cancer

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st line for HER2+, 1st-3rd line for HER2-

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

PI

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Key Eligibility Criteria Details
  • Men or women

  • Metastatic or locally advanced or recurrent breast cancer

  • If HER2 negative, no more than two prior chemotherapy lines in metastatic disease and no prior anthracycline

  • If HER2 positive, must have received prior therapy with trastuzumab and must not have received prior TDM1

  • Must have prior treatment with a taxane and trastuzumab in any setting

    • If treated in 2nd line or later, must have progressive disease since last regimen

    • If treated in 1st line metastatic, must have progression within 6 months of completing adjuvant therapy

  • Tumor specimen must be obtained after the most recent breast cancer systemic therapy

  • ECOG PS 0-2

  • Measurable disease

  • LVEF >50% by ECHO or MUGA

  • Adequate labs

  • No known CNS disease except for treated asymptomatic supratentorial mets with no need for active steroids

  • No leptomeningeal disease

  • No grade 2 or higher peripheral neuropathy
  • No history of autoimmune disease or need for current immunosuppressants
  • No HVB/HCV/HIV

 

BREAST: METASTATIC: Triple Negative: 1st line or >2nd Line: “CX-839-007”
A multicenter phase 2 study of the glutaminase inhibitor CB-839 in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC) including patients of African ancestry and non-African ancestry VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to enrollment

Line Of Therapy

Cohorts 2 and 4- 1st line; Cohorts 1 and 3- 3rd line or higher

Investigational Agent

CB-839

Drug Class

Glutaminase Inhibitor

PI

Greg Vidal, MD

Sponsor

Calithera Biosciences, Inc.

Key Eligibility Criteria Details
  • Females >18 years old

  • TNBC defined as ER/PR <1%, HER2 negative

  • ECOG PS 0-1

  • Labs within standard limits

  • No known CNS disease unless adequately treated with XRT or surgery and stable by symptoms for at least 2 months prior

  • No other malignancy within 3 years (except non-melanoma skin cancer or in situ cancers)

  • No unstable cardiac disease

  • No known sensitivity Cremaphor

  • Cohort 1- 3rd+ line in African ancestry

    • Must have received prior taxane for metastatic disease but not in most recent treatment

    • Adjuvant therapy counts as therapy if time to recurrence <12 months

  • Cohort 2- 1st line in African ancestry- no prior systemic tx for advanced disease

    • Adjuvant therapy only allowd if time to recurrence >12 mo

  • Cohort 3- 3rd+ line in non-African ancestry

    • Similar to Cohort 1

  • Cohort 4- 1st line in non-African ancestry

    • Similar to cohort 2

BREAST: METASTATIC: Stable brain mets; prior taxane, anthracycline, capecitabine: “ATTAIN”
A Phase 3 open-label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine (ATTAIN) VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer, stable brain metastases, MBC

Stage

Stage 4

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

NEKTR 102 (etirinotecan pegol)

Drug Class

pegylated pro-drug

PI

Lee Schwartzberg, MD

Sponsor

Nektar Therapeutics

Key Eligibility Criteria Details
  • Any gender

  • Single-agent cytotoxic chemotherapy indicated

  • Can be measurable or non-measurable disease

  • Must have a history of brain metastases that are non-progressing

  • In TNBC, must have at least 1 prior lines of metastatic cytotoxic therapy

  • In non-TNBC, prior therapy as indicated is required

  • Have received prior therapy with anthracycline, taxane, and capecitabine in any setting (neo-adj, adj, or metastatic)

  • Most recent anti-cancer therapy within 6 months of randomization

  • ECOG PS 0-1

  • No prior SCT

  • No prior camptothecin-derived agent

  • No leptomeningeal disease

  • No HBV/HCV/HIV

  • No cirrhosis

  • No other malignancy within 5 years

  • No need for O2 supplementation

COLON/RECTAL: Metastatic: 2nd Line: “CanStem303C”

A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colon, metastatic CRC, rectal cancer, colorectal, rectum

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

BBI-608 (napabucasin)

Drug Class

STAT3 inhibitor

PI

Brad Somer, MD

Sponsor

Boston Biomedical, Inc.

Key Eligibility Criteria Details
  • Metastatic histologically confirmed CRC
  • Must have failed treatment with one regimen containing a fluoropyrimidine and oxaliplatin for metastatic disease. All patients must have received a minimum of 6 weeks of the first line therapy. Treatment failure is defined as radiologic progression during or <6 months after the last dose of first-line therapy (including adjuvant)
  • ECOG PS 0-1
  • Must give access to either archived or new biopsy
  • No more than 1 prior chemo regimen in metastatic setting
  • No other cancers within 3 years 
HEAD AND NECK: PHASE 1: Combo Immunotherapy: "CA223-001:

A phase 1 dose escalation and cohort expansion study of the safety, tolerability and efficacy of anti-KIR (lirilumab) administered in combination with anti-PD-1 (nivolumab) in advanced refractory solid tumors (CA223-001)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Head and Neck Cancer (Larynx, Oral cavity, Oropharynx, Hypopharynx), SCCHN

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or later

Investigational Agent

Nivolumab, Lirilumab

Drug Class

PD-1 inhibitor, anti-KIR antibody

PI

Moon Fenton, MD, PhD

Sponsor

Bristol-Myers Squibb

Key Eligibility Criteria Details
  • Histologically confirmed incurable locally advanced, recurrent or metastatic SCCHN stage III/IV and not amenable to local therapy with curative intent (surgery or XRT with or without chemo)
  • Confirmation of tumor HPV status
  • Tumor progression or recurrence within 6 months of last dose of platinum therapy in either the adjuvant, primary, recurrent, or metastatic setting
  • Measurable disease by RECIST
  • ECOG PS 0-1
  • No known CNS mets
  • No prior or concurrent malignancies
  • No history of autoimmune disorders
  • No prior tx with PD-1, anti-KIR, or anti-CTLA4 therapy
  • No RANK-L inhibitors within 10 weeks, no bisphosphonates within 4 weeks
  • No known HIV/HBV/HCV
LEUKEMIA: CLL; High-risk or Relapsed/Refractory; “CLL-001”

Phase 1/2 study to determine the safety, pharmacokinetics, and efficacy of single agent CC-122 and the combinations of CC-122 and ibrutinib and CC-122 and obinutuzumab in subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Leukemia, CLL, Chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma

Stage

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st line or later for high-risk disease; 2nd line or later for relapsed/refractory disease

Investigational Agent

CC-122

Drug Class

Thalidomide analog/immune effect modulator

PI

Jason Chandler, MD

Sponsor

Celgene

Key Eligibility Criteria Details
  • ECOG PS 0-1

  • Age 18-80 years old

  • Must have CLL/SLL requiring treatment per Hallek, 2008

  • Must have at least one clinically measurable lesions defined as

    • Nodal lesion measuring >1.5cm in longest diameter and >1.0cm in longest perpendicular diameter OR

    • Spleen measuring >14cm in longest vertical dimension with a minimum of 2 cm enlargement OR

    • Liver measuring >20 cm in longest vertical dimenstion with a minimum of 2 cm of enlargement OR

    • Peripheral blood B lymphocyte count >5000/uL

  • For single agent and obinutuzumab combo must have relapsed refractory disease as follows:

    • Must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor unless significant co-morbidities or contraindications

  • For ibrutinib combo arm, must have not received prior treatment with ibrutinib or BTK inhibitors and must have high-risk disease defined as follows:

    • 17p- and/or TP53 mutation positive in treatment naïve CLL OR

    • 17p- and/or TP53 mutation positive, and/or complex karyotype and/or progression <24 months after completion of 1st line chemoimmunotherapy in relapsed/refractory CLL

  • Subjects with R/R SLL or CLL with bulky disease (LN>5.0cm) may only be enrolled after discussion with sponsor medical monitor

  • Must have adequate lab values

  • No prior allo or auto SCT within 12 months

  • No known HIV/HBV/HCV

  • No significant peripheral neuropathy

  • No impaired cardiac function

LUNG: Stage 1; Surgery vs. XRT; JOLT: "STABLE-MATES"

JoLT-Ca A randomized phase III study of sublobar resection (SR) versus stereotactic ablative radiotherapy (SAbR) in high risk patients with stage I non-small cell lung cancer (NSCLC), the STABLE-MATES trial

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung cancer, Early lung cancer; NSCLC

Stage

Stage 1

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Primary treatment

Investigational Agent

SR vs. SAbR

Drug Class

Surgery vs. XRT

PI

Benny Weksler, MD

Sponsor

University of Texas Southwestern Medical Center

Key Eligibility Criteria Details
  • Radiographic findings c/w and biopsy proven NSCLC
  • Tumor <4 cm maximum diameter (clinical stage IA and selected IB within 60 days of tx)
  • All clinically suspicious mediastinal nodes confirmed negative for cancer histologically
  • Tumor verified by thoracic surgeon to be in a location that will permit sublobar resection
  • Tumor must be peripheral (not touching any surface within 2 cm of proximal bronchial tree)
  • Patient must be at high risk for surgery by meeting 1 major or 2 minor criteria
  • No prior malignancy unless disease free for >3 years (except skin CA and in-situ disease)
  • No evidence of distant mets
  • No prior intrathoracic radiation therapy
  • ECOG PS 0-2
LUNG CANCER: Brain metastases: XRT Device: "METIS"

Pivotal, open-label, randomized study of radiosurgery with or without tumor treating fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung Cancer; NSCLC, non-small cell lung cancer; brain metastases

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

NovoCure TTFields

Drug Class

Device administering alternating electrical fields

PI

Matt Ballo, M.D.

Sponsor

NovoCure Ltd.

Key Eligibility Criteria Details
  • New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
  • KPS >70
  • 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
    • Largest tumor volume < 10cc
    • Longest tumor diameter < 3cm
    • Cumulative volume of all tumors < 15cc
  • At least one measurable lesion per RANO-BM
  • May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
  • Patient must be able to operate NovoTTF-100M device independently or with caregiver
  • No ALK/ROS-1 alterations. No BRAF, EGFR mutations
  • No significant edema with risk of brain herniation
  • No midline shift > 10mm
  • No intractable seizures
  • No infratentorial or leptomeningeal mets
  • No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
  • No implantable electronic medical devices in the brain
  • No other concurrent brain directed therapy
LUNG: EGFR mutation; "Checkmate 370"

A master protocol of Phase 1/2 studies of nivolumab in advanced NSCLC using nivolumab as maintenance after induction chemotherapy or as first-line treatment alone or in combination with standard of care therapies

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Metastatic Lung Cancer, NSCLC, squamous cell lung cancer, lung adenocarcinoma, non-small cell lung cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Jason Chandler, MD

Sponsor

Bristol-Myers Squibb

Key Eligibility Criteria Details
  • Locally advanced or metastatic NSCLC
  • For currently open cohort must have EGFR mutation
  • ECOG PS 0-2
  • Tumor tissue available for biomarker evaluation
  • No active CNS involvement
  • No known or active autoimmune disease
  • No known HIV, HBV, HCV
LUNG: METASTATIC: PHASE 1: PD-1 NAIVE: 2nd Line: "PROPEL LUNG"

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination WithAnti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd (1st if patient refuses platinum-based therapy)

Investigational Agent

NKTR-214, atezolizumab

Drug Class

pegylated IL-2, PD-L1 inhibitor

PI

Dan Vaena, MD

Sponsor

Nektar Therapeutics

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed non-small cell lung cancer lacking EGFR sensitizing mutations and lacking ALK translocation
  • ECOG PS 0-1
  • Measurable disease per RECIST 1.1
  • No prior receipt of immunotherapy with immunomodulators (eg. PD-1 inhibitors, CTLA-4 inhibitors, IDO inhibitors)
  • Either;
    • No more than 1 prior line of platinum-containing therapy with disease progression on or following this therapy OR
    • Patient refuses standard of care therapy in the 1st line
  •  No history of or active autoimmune disease (exceptions include Hashimoto's thyroiditis, Graves' disease, TIDDM, or Med Monitor approval)
LUNG: Metastatic: Phase 1: 2nd line or later: "FRACTION-LUNG LAG-3/dasatinib"

A phase 2, fast real-time assessment of combination therapies in immune-oncology study in subjects with advanced non-small cell lung cancer (FRACTION-LUNG)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or later

Investigational Agent

BMS-986016, dasatinib, nivolumab

Drug Class

anti-LAG-3 antibody, multi-kinase inhibitor, PD-1 antibody

PI

Ari VanderWalde, MD

Sponsor

Bristol-Myers Squibb

Key Eligibility Criteria Details
  • Metastatic Non-small cell lung cancer
  • At least 1 prior line of therapy (2nd line or later)
    • Current arms require patients to be PD-1 naive (this will change)
  • Patients with EGFR or ALK alterations must have received targeted therapy
  • Measurable disease
  • Palliative XRT must be completed at least 2 weeks prior to enrollment
  • Biopsies required pre-treatment, on-treatment, and at progression
  • No active CNS mets
  • No prior malignancy unless CRR achieved at least 2 years prior and no active therapy required
  • No systemic therapy within 4 weeks of enrollment
  • No active autoimmune disease (except skin disorders, hypothyroidism, T1DM)
  • No severe toxicity due to prior immune therapy
  • No symptomatic interstitial lung disease
  • No known HIV/HBV/HCV
LUNG: Metastatic; NSCLC; Phase 1; CDK4/6 inhibitor; "I3Y-MC-JPBJ"

A phase 1b study of LY2835219 in combination with multiple single agent options for patients with stage IV NSCLC

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung cancer; NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line (Group E only), 3rd or 4th line

Investigational Agent

LY2835219

Drug Class

CDK4/6 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Eli Lilly and Company

Key Eligibility Criteria Details

Stage IV NSCLC
ECOG PS 0-1
Off all anti-cancer tx for at least 21 days
No CNS mets
No serious cardiac history (except chronic afib)



Part D (abemaciclib + LY3023414)

At least 3rd line but no more than 4th line
No prior tx with a PI3K or mTOR inhibitor
No history of ILD

Part E (abemaciclib + pembrolizumab)

At least 2nd line but no more than 4th line.

LYMPHOMA: NHL; DLBCL; Phase 1; "CC-122-DLBCL-001"

A phase 1b, multi-center, open-lable study of novel combinations of CC-122, CC-223, CC-292 and rituximab in diffuse large B-cell lymphoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lymphoma, Diffuse Large B-cell lymphoma, DLBCL

Stage

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>2nd line

Investigational Agent

CC-122 and/or CC-223 and/or CC-292

Drug Class

anti-CRBN (CC-122); mTOR kinase inhibitor (CC-223); BTK ihibitor (CC-292)

PI

Daruka Mahadevan, MD, PhD

Sponsor

Celgene Corporation

Key Eligibility Criteria Details

Biopsy proven DLBCL
Relapsed or refractory to standard treatment
ECOG PS 0-1
Measurable disease
ANC>1.5, plts>50
No CNS involvement
No impared cardiac function
No active tx for diabetes (if on CC-223 arm only)
No prior allo HCT
No auto HCT within 3 months
No systemic anti-cancer tx within 4 weeks_

MELANOMA: Adjuvant: Stage III-IV(resected): Immunotherapy: "SWOG S1404"

A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Skin Cancer, Melanoma, Cutaneous Melanoma, Mucosal Melanoma

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

SWOG

Key Eligibility Criteria Details
  • Completely resected cutaneous or mucosal melanoma (or unknown primary)

  • Stage IIIB, IIIC, or IV (M1a, M1b, or M1c allowed). IIIA allowed only if N2a

  • May be eligible either at initial presentation or following resection of recurrence

  • Must have undergone wide excision of primary lesion (if present)

  • Full lymphadenectomy required for all patients with positive sentinel nodes

  • Must be registered within 98 days of final surgery for melanoma

  • Must have 5 unstained slides available from original or current tumor

  • Must be disease free on scans within 42 days of therapy

  • ECOG PS 0-1

  • No prior systemic therapy for melanoma

  • Prior radiation is allowed

  • No brain mets (or history of brain mets)

  • No autoimmune disease

  • No HBV or HCV

  • HIV allowed if CD4 counts >350, viral load <25,000

MELANOMA: Metastatic: BRAFmt: "20149189"

A Phase 1b trial of talimogene laherparepvec in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Skin cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, provided no prior therapy with T-VEC or combination of dabrafenib/trametinib

Investigational Agent

Talimogene laherparepvec (T-VEC)

Drug Class

Oncolytic virus

PI

Ari VanderWalde

Sponsor

West Cancer Center/Amgen

Key Eligibility Criteria Details
  • Age >18 years at the time of informed consent
  • Histologically confirmed diagnosis of melanoma
  • Primary or recurrent Stage IIIB to IV M1c disease for whom surgery is not recommended
  • Must have an activating BRAF mutation (limited to V600E or V600K mutations if subject is being treated first line, but can include any well-defined BRAF mutation after failure of prior immunotherapy)
  • Measurable disease per RECIST 1.1
  • Injectable disease defined as either of the following:
    • At least one injectable cutaneous, subcutaneous, or nodal melanoma lesion >10mm in longest diameter
    • Multiple injectable melanoma lesions that in aggregate have a longest diameter of >10mm
  • ECOG Performance Status 0-1
  • Any number of prior treatment regimens, provided that subject has not previously received T-VEC or combination of dabrafenib/trametinib
  • No clinically active CNS mets
  • No active herpes infection or prior complications of herpetic infections
  • No known HIV, HBV, HCV
  • No known severe autoimmune disease
MELANOMA: Metastatic; 1st line; T-VEC+PD-1; "MASTERKEY-265"

A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected,Stage IIIB to IVM1c Melanoma (MASTERKEY-265)_

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, skin cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Talimogene laherparepvec, pembrolizumab

Drug Class

oncolytic virus, PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Amgen

Key Eligibility Criteria Details
  • Unresected Stage IIIB, IIIC, or IV melanoma
  • No prior therapy for metastatic disease
  • At least 6 months from adjuvant therapy
  • No clinically active CNS disease
  • ECOG PS 0-1
  • Measurable (at least 1 lesion >1cm)
  • Injectable (total cutaneous/subcut/nodal lesions >1cm in aggregate)
  • No prior ipilimumab, PD-1 inhibitors, T-VEC or tumor vaccines
  • Previous BRAF or MEK inhibitors allowed if BRAF mutated
  • No primary uveal or mucosal melanoma
  • No prior intrathoracic XRT
MELANOMA: OCULAR MELANOMA: Metastatic: Hepatic dominant: Any line: "FOCUS"

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Ocular melanoma, hepatic metastases, skin

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Metastatic Any Line

Investigational Agent

Percutaneous hepatic perfusion of melphalan

Drug Class

Percutaneous hepatic perfusion

PI

Evan Glazer, MD

Sponsor

Delcath Systems Inc.

Key Eligibility Criteria Details
  • Histologically or cytologically proven ocular melanoma to the liver
  • No more than 50% liver parenchema involvement
  • Evidence of limited extrahepatic disease allowed as long as life threatening component of disease is in liver
  • ECOG PS 0-1
  • No Child Class B or C cirrhosis
  • No active HBV or HCV
  • No active CNS mets
MULTIPLE MYELOMA: 3rd line or higher: combo immunotherapy: "Checkmate 602"

An open label, randomized phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide and dexamethasone in relapsed and refractory multiple myeloma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Multiple Myeloma

Stage

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd line or greater

Investigational Agent

Nivolumab, elotuzumab

Drug Class

PD-1 inhibitor, SLAMF7 mAb

PI

Jason Chandler, MD

Sponsor

Bristol-Myers Squibb

Key Eligibility Criteria Details
  • Multiple myeloma
  • Refractory (progressed on or within 60 days) to most recent treatment
  • Must have received >2 lines of prior therapy which must have included at least 2 consecutive cycles of each immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination
  • Measurable disease at screening defined as one or more of the following:
    • Serum IgG, IgA, or IgM M-protein >0.5 g/dL
    • Urine M-protein >200 mg excreted in 24-hour collection sample
    • Involved serum free light chain >100 mg/L provided the FLC ratio is abnormal
  • ECOG PS <2
  • No prior treatment with pomalidomide, elotuzumab, or any PD-1/PD-L1 inhibitor
  • No MGUS, Smoldering myeloma, Waldenstrom’s, amyloidosis, POEMS syndrome, or active plasma cell leukemia (20% peripheral blood of plasma cells or absolute plasma cell count of 2 x10^9/L)
  • No active autoimmune disease
  • No active infection or uncontrolled severe CV or pulmonary disease
  • No chronic steroid use within 14 days of enrollment
  • No known HBV/HCV/HIV
  • No Grade >2 peripheral neuropathy
  • Auto transplant allowed as long as at least 12 weeks prior
  • Allo transplant allowed as long as at least 1 year prior
PANCREAS: Metastatic: 1st line: "NLG2104"

A phase I/II study of indoximod in combination with gemcitabine and nab-paclitaxel in patients with metastatic adenocarcinoma of the pancreas

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Pancreas, Pancreatic cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st

Investigational Agent

Indoximod

Drug Class

IDO inhibitor

PI

Brad Somer, MD

Sponsor

NewLink Genetics Corporation

Key Eligibility Criteria Details

Stage IV Adenocarcinoma of the pancreas
Diagnosed with metastatic disease within 8 weeks
At least 1 measurable lesion. No "nodal only" disease
No prior therapy for metastatic disease
At least 6 months since adjuvant tx (if received)
No prior immune therapy for cancer
No brain mets
No active autoimmune disease

OVARIAN: METASTATIC: Platinum Resistant: PHASE 1: 2nd to 5th line: “KEYNOTE-162 Ovarian”

Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line to 5th line

Investigational Agent

Niraparib, Pembrolizumab

Drug Class

PARP inhibitor, PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Tesaro, Inc

Key Eligibility Criteria Details
  • High-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have recurrent disease and have been previously treated with chemotherapy for advanced/metastatic disease and who experience a response lasting at least 6 months to first-line platinum based-therapy but currently considered platinum-resistant
  • Up to 4 lines of prior therapy allowed in Phase 1 portion, Up to 3 lines allowed in Phase 2 portion
  • May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
  • No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
  • No chronic systemic steroid use
  • No active autoimmune disease that has required treatment in last 2 years
  • No history of interstitial lung disease
  • No history of platelet transfusion for chemo-induced thrombocytopenia
  • No prior anti-PD1 or PARP therapy
PROSTATE: METASTATIC: CASTRATE RESISTANT: DNA-Repair mutation: "PROfound"

A phase III, open label, randomized study to assess the efficacy and safety of olaparib (Lynparza) versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations (PROfound)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd (Following failure of one anti-androgen)

Investigational Agent

Olaparib

Drug Class

PARP inihibitor

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Key Eligibility Criteria Details
  • Metastatic castration resistant prostate cancer
  • Progression on abiraterone or enzalutamide but not both
  • Prior anti-cancer therapy (e.g. docetaxel) permitted but not required
  • Ongoing therapy with LHRH analog or orchiectomy
  • Qualifying HRR mutation in tumor tissue (see path tab for full complement of qualifying mutations)
  • No prior treatment with PARP inhibitor
  • No prior treatment with platimum or mitoxantrone
  • No known brain metastases
  • No other malignancy within 5 years
RENAL: Metastatic: 1st Line: Immunotherapy+Targeted Therapy: “KEYNOTE 426”

A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Renal cell carcinoma, RCC, kidney cancer, clear cell RCC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Pembrolizumab and Axitinib

Drug Class

PD-1 inhibitor, VEGF TKI

PI

Brad Somer, MD

Sponsor

Merck, Sharp, & Dohme Corp

Key Eligibility Criteria Details
  • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features

  • Stage IV disease (locally advanced/metastatic)

  • Measurable disease

  • No prior systemic therapy for advanced RCC

  • Archival or new tissue sample required

  • KPS >70%

  • If receiving bone resorptive therapy must have been on stable dose at least 4 weeks

  • Adequate organ function

  • No prior treatment with immunotherapy (eg. PD-1, GITR, IDO inhibitors)

  • No VEGF or mTOR targeting agents within 12 months

  • No active autoimmune disease

  • No other malignancy within last 3 years

  • No active CNS disease

  • No known HIV, HBV, HCV

  • No severe cardiovascular disease

MOLECULARLY TARGETED: MSI-h, TML-h: >/=2nd Line: "MY PATHWAY- MSI, TML"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Drug Class

PI

Sponsor

Key Eligibility Criteria Details
  • PD-L1 copy number gain/amplification (likely available on Foundation only)
  • Patients with MSI-high
    • Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
  • Patients with dMMR
    • Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
  • Patients with total mutational burden high
    • As determined by FoundationOne
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
MOLECULARLY TARGETED: ALK alteration: METASTATIC: >/= 2nd Line: "MY PATHWAY- ALK"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

Alectinib

Drug Class

ALK inhibitor

PI

Ari VanderWalde

Sponsor

Genentech, Inc.

Key Eligibility Criteria Details
  • Metastatic solid tumor
  • ALK alterations as follows
    • ALK gene rearrangements by NGS or FISH using Vysis ALK Break Apart FISH Probe Kit
    • Activating non-synonymous mutations in and around the ALK kinase domain by NGS
    • ALK copy number gains by NGS
    • Patients with melanoma and high ALK expression by IHC
  • ECOG PS 0-2
  • No prior treatment with any ALK inhibitor
  • Following tumor types are not eligible
    • Non-small cell lung cancer (NSCLC)
    • Neuroblastoma
    • Childhood tumors
MOLECULARLY TARGETED: BRAF mut: Metastatic; >/= 2nd line; "My Pathway- BRAF"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Genital tract (bladder, kidney, ureter), ovarian (ovary), biliary tract (bile duct), endometrial (uterus), prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> or equal to 2nd line

Investigational Agent

Vemurafenib and Cobimetinib

Drug Class

BRAF inhibitor + MEK inhibitor

PI

VanderWalde

Sponsor

Genentech, Inc.

Key Eligibility Criteria Details


Metastatic solid tumor_
No known RAS mutation
No melanoma, papillary thyroid, colorectal, or hematologic malignancies2nd line or greater
ECOG PS 0-2
No prior treatment with any BRAF inhibitor (sorafenib is allowed)
No prior treatment with a MEK inhibitor
No active or untreated CNS metastastasis

MOLECULARLY TARGETED: EGFR mut: Metastatic; >/= 2nd line; "My Pathway- EGFR"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Peritoneum, Prostate, CNS (brain), stomach (gastric), ovarian, adrenal, biliary tract (bile duct), salivary gland, thyroid, kidney (RCC), urinary tract (bladder), Head and neck (SCCHN), esophagus

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

erlotinib

Drug Class

EGFR inhibitor

PI

VanderWalde

Sponsor

Genentech, Inc.

Key Eligibility Criteria Details


Metastatic cancer
EFGR activatingmutation (not exon 20)
NSCLC or pancreatic must not haveexon 19 deletions or exon 21 L858R substitution2nd line or greater
ECOG PS 0-2
No prior treatment with any EGFR inhibitor
No active or untreated CNS metastastasis

MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB3mt: "NER-5201"
An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Bladder, Urothelial, Kidney, Renal cell, RCC, Endometrial, Uterine, Gastric, Esophageal, Gastroesophageal, Ovarian, Breast, Lung, Prostate, Hepatic, Head and Neck

Stage

Stage 4

Phase

Phase 2

Status

Open to enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Key Eligibility Criteria Details
  • Histologicall confirmed cancer for which no curative therapy exists
  • CRC or primary brain tumors are excluded (cohorts full)
  • Documented HER2 or HER3 mutation. HER2 mutations in lung or colorectal cancers are ineligible.
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
MOLECULARLY TARGETED: HER2 mut/expr: Metastatic; >/= 2nd line; "My Pathway-HER2"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Ovarian (ovary, ovarian cancer); CNS (brain cancer, central nervous system); Liver (hepatocellular, HCC), Lung (SCLC, NSCLC); Head and neck (SCCHN; oropharynx, larynx, hypopharynx, oral cavity); colon (colorectal, CRC); pancreatic; breast; gastric

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> 2nd line

Investigational Agent

trastuzumab/pertuzumab

Drug Class

anti-HER2 monoclonal antibodies

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Key Eligibility Criteria Details


Metastatic solid tumor
HER2 overexpression, amplification, or HER2 activating mutation
Breast, gastric, or GE junction may enter only if HER2 mutation2nd line or greater
ECOG PS 0-2
No prior treatment with any HER-2 directed therapy
No active or untreated CNS metastastasis
LVEF must be>_50%

MOLECULARLY TARGETED: PTCH/SMO mut: Metastatic; >/= 2nd line; "My Pathway- PTCH/SMO"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Head and neck (SCCHN, oropharynx, larynx, hypopharyx, oral cavity); liver (hepatocellular, HCC); ovarian; colorectal (colon, CRC); esophageal, CNS (brain), breast, lung

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Vismodegib

Drug Class

Hedgehog inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Key Eligibility Criteria Details


Metastatic solid tumor
Loss of function mutation in PTCH or gain of function mutation in SMO
No basal cell CA, medulloblastoma, or SCLC2nd line or greater
ECOG PS 0-2
No prior treatment with any hedgehogdirected therapy
No active or untreated CNS metastastasis_

MOLECULARLY TARGETED: PIK3CA mutations: "PMT4979g"
An open-label, phase I/II, dose-escalation study evaluating the safety and tolerability of GDC-0032 in patients with locally advanced or metastatic solid tumors or non-Hodgkin's lymphoma and in combination with endorcrine therapy in patients with locally advaned or metastatic hormone receptor-positive breast cancer. VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced tumors; bladder, head and neck (SCCHN), gastric, triple negative breast cancer (TNBC), ovarian, cervical, colorectal, squamous, ovarian

Stage

Stage 4

Phase

Phase 1

Status

Open to enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

taselisib (GDC-0032)

Drug Class

PI3 kinase delta inhibitor

PI

Ari VanderWalde, MD

Sponsor

Hoffman-La Roche

Key Eligibility Criteria Details
  • Advanced solid malignancies with PIK3CA mutations (see "malignancies" tab for current eligible disease states)
  • No  untreated or active CNS mets
  • No diabetes requiring active treatment
  • No active CHF or ventricular arryhtmias requiring treatment
  • Measurable disease via RECIST 1.1
  • ECOG PS 0-1
  • No O2 requirements
  • No XRT within previous 2 weeks (for bony mets) or 4 weeks for all other reasons
  • No requirements for immunosuppression

      ADVANCED TUMORS: Metastatic: Immunotherapy combination: ≥2nd line: “Keynote-037”

      A Phase 1/2 study exploring the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with epacadostat (INCB024360) in subjects with selected cancers

      VIEW TRIAL ON CLINICALTRIALS.GOV
      Malignancy

      MSI-high colorectal (CRC, colon, rectum); Hepatocellular carcinoma (HCC, liver); Gastric (Stomach)

      Stage

      Stage 4

      Phase

      Phase 2

      Status

      Open to Enrollment

      Line Of Therapy

      ≥2nd line

      Investigational Agent

      Epacadostat and Pembrolizumab

      Drug Class

      IDO inhibitor and PD-1 inhibitor

      PI

      Brad Somer, MD

      Sponsor

      Incyte Corporation

      Key Eligibility Criteria Details
      • ECOG PS 0-1
      • Fresh baseline tumor biopsies are required unless med monitor approval
      • No active ILD or pneumonitis
      • No active receipt of steroids within 7 days or known immunodeficiency
      • No prior anti-PD-1 or CTLA-4 treatment
      • No known or active CNS mets
      • No history of autoimmune disease
      • For MSI-high CRC
        • MMR or MSI status is, respectively, determined by examining either CRC tumor: protein expression by IHC of 4 MMR enzymes (MLH1/MSH2/MSH6/PMS2) or 3 to 5 tumor microsatellite loci using PCR-based assay. Tumors are classified as MSI high when at least 2 allelic shifts among the 3 to 5 analyzed microsatellite markers are detected by PCR or absence of at least 1 of 4 MMR protein expression is detected by IHC
      • For Gastric cancer
        • Must have documentation of HER2 status. IF HER2+ must have progressed or been intolerant of HER2 directed therapy
        • No more than 2 prior lines of therapy
      • For Hepatocellular carcinoma
        • Must be Child-Pugh Class A
        • Must be Barcelona Clinic Liver Cancer Stage C disease (or Stage B disease and either refractory to or not amenable to locoregional therapy
        • No more than 2 lines of prior therapy
        • Must have progressed on or intolerant to sorafenib
        • No history of liver transplant, clear invasion of bile duct or main portal branch, hepatorenal syndrome, or required esophageal variceal ablation within 28 days of study start
        • HBV/HCV only allowed if meet certain criteria
      • For melanoma- (COHORT CLOSED)
        • Known BRAF status
        • No ocular melanoma
      • For bladder/transitional cell (COHORT CLOSED)
        • TCC of bladder, ureter, or renal pelvis
        • 2nd line after progression on platinum (if no platinum received must have documented why unable to tolerate)
      • For RCC (COHORT CLOSED)
        • Clear cell histology
        • Following progression on therapies with established clinical benefit
      • For NSCLC (COHORT CLOSED)
        • 2nd line or later after platinum based therapy for metastatic disease
        • If EGFR or ALK positive, must have received targeted therapy
        • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
      • For SCCHN (COHORT CLOSED)
        • No nasopharyngeal, salivary gland, or non-squamous histology
        • 2nd line or later after failure of platinum-based therapy
        • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
      • For DLBCL
        • No prior allo transplants
        • 2nd line or later
        • Not a candidate for curative tx or SCT
      •  
      ADVANCED SOLID TUMORS: Phase 1: Immunotherapy Combination: "NIVO-GITR"

      A Phase 1/2a dose escalation and cohort expansion study for safety, tolerability, and efficacy of BMS-986156 administered alone and in combination with nivolumab in advanced solid tumors

      VIEW TRIAL ON CLINICALTRIALS.GOV
      Malignancy

      Non-small cell lung cancer (NSCLC), cervical cancer, bladder cancer (urothelial cancer, transitional cell carcinoma), head and neck (SCCHN, larynx, oropharynx, hypopharynx, oral cavity), ovarian cancer, hepatocellular carcinoma (HCC)

      Stage

      Stage 4

      Phase

      Phase 1

      Status

      Open to Enrollment

      Line Of Therapy

      2nd line or later

      Investigational Agent

      BMS-986156 and nivolumab

      Drug Class

      GITR agonist, anti-PD-1 antibody

      PI

      Greg Vidal, MD

      Sponsor

      Bristol-Myers Squibb

      Key Eligibility Criteria Details
      • Measurable disease

      • NSCLC

        • If EGFR mut or ALK positive must have received targeted therapy

        • Must have progressed on both platinum doublet and PD-1 therapy

      • Cervical Cancer

        • Persistent, recurrent, or metastatic disease

        • Squamous, adenosquamous or adenocarcinoma histology

        • At least one prior platinum based regimen

        • Confirmation of HPV status

      • Bladder cancer

        • Transitional cell carcinoma involving bladder, urethra, ureter, or renal pelvis

        • Minor histologic variants are acceptable

        • Must have progression or recurrence with platinum-containing regimen (in metastatic setting or within 12 months of peri-operative setting)

      • SCCHN

        • Must have documented HPV status and subtype

        • Prior treatment with platinum containing regimen with progression or recurrence within 6 months of last dose

        • Cannot be amenable to local therapy with curative intent

      • Ovarian

        • Can include epithelial ovarian, primary [peritoneal, or fallopian tube cancer

        • Must have received at least 1 standard systemic therapy for metastatic disease

      • HCC

        • Progressive disease to at least one line of therapy or refuse treatment with sorafenib

        • Child-Pugh score of 6 or less. No encephalopathy and Tbili must be <1.5x ULN

        • HBV and HCV must be tested. HBV viral load <100 IU/mL and must be on anti-viral therapy

        • No clinical ascites or variceal bleeding

      • No more than 5 prior lines of treatment

      • Acceptable lab parameters

      • No active CNS metastatases (treated brain mets may be allowed)

      • No prior malignancy within 2 years (except for in-situ or non-melanoma skin)

      • No autoimmune disease, interstitial lung disease, or requiring immunosuppressive meds

      ADVANCED TUMORS: Metastatic; PD-1 monotherapy; “Checkmate 627”

      An open label phase 2 multi-cohort trial of nivolumab in advanced or metastatic malignancies

      VIEW TRIAL ON CLINICALTRIALS.GOV
      Malignancy

      Anal cancer, carcinoid, endometrial (uterine), non-squamous head and neck, histiocytoses, Lynch syndrome associated cancer, medullary thyroid, merkel cell carcinoma, skin cancer, mesothelioma, nasopharyngeal, poorly differentiated neuroendocrine, non-lung small cell, penile, rare women's cancers, testicular, thymoma/thymic carcinoma, papillary or follicular thyroid, uterine sarcoma (leiomyosarcoma), vulvar cancer, small bowel, adrenocortical, appendicial (appendix),

      Stage

      Stage 4

      Phase

      Phase 2

      Status

      Open to Enrollment

      Line Of Therapy

      2nd line or later (unless no primary therapy standard)

      Investigational Agent

      Nivolumab

      Drug Class

      PD-1 inhibitor

      PI

      Lee Schwartzberg, MD

      Sponsor

      Bristol-Myers Squibb

      Key Eligibility Criteria Details
      • Measurable disease required
      • ECOG PS <1
      • Brain mets allowed but must not be active, cannot require steroids, have at least one measurable lesion outside of brain
      • Excluded tumors:
        • No Pancreatic
        • No endometrial with ER>10%
        • No ovarian
        • No breast
        • No esophageal
        • No gastric
        • No glioma
        • No hepatocellular carcinoma
        • No lymphoma (except primary CNS lymphoma)
        • No leukemia
        • No melanoma
        • No MDS
        • No lung cancer
        • No renal cell
        • No bladder
      • Must not have had other cancer within 2 years
      • No prior PD-1/L-1 or CTLA-4 therapy
      • No autoimmune disease
      • No active steroids
      • No known HIV, HBV, or HCV
      • See "malignancy" list for accepted tumor types