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MELANOMA: NEOADJUVANT: STAGE III: KEYNOTE U02-C

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab, MK-7684, V937

Drug Class

Anti-PD-1, Anti-TIGIT, Oncolytic virus

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed melanoma
  • Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
  • Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
  • No known CNS mets
  • No ocular or mucosal melanoma
  • No known HIV/HBV/HCV
  • No active autoimmune disease requiring therapy in past 2 years
  • Must not have received prior oncolytic viruses
MELANOMA:Metastatic: 1st Line: KEYNOTE-U02-B

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02B.

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line, PD-1 naive

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease
  • No ocular or mucosal melanoma
  • No known additional malignancy that is progressing or requires active treatment within the past two years
  • No known CNS metastatses
  • No active autoimmune disease requiring systemic treatment in the past two years
  • No known HIV/HBV/HCV
  • Adequate organ function
MELANOMA: Metastatic: PD-1 refractory: KEYNOTE-U02-A

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02A.

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Malignancy

Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line (post PD-1)

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma not amenable to curative therapy
  • Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
  • Hsa not received more than 3 lines of therapy
  • No known additional malignancy with past 2 years
  • No known CNS metastases
  • No active autoimmune disease requiring systemic treatment in the last 2 years
  • No known HIV/HBV/HCV
MELANOMA: 2nd line: PD-1 + HSV-virus: RPL-001-16

An open-label, multicenter, Phase 1/2 study of RP1 as a single agent and in combination with PD1 blockade in patients with solid tumors

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Malignancy

Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd

Investigational Agent

RP1 + nivolumab

Drug Class

Oncolytic virus

PI

Ari VanderWalde, MD

Sponsor

Replimune Inc.

Path

Melanoma

Key Eligibility Criteria Details
  • Stage IIIB-IV melanoma, following progression on PD-1 containing regimen
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measruable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
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

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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.

Path

Ocular melanoma

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
SKIN CANCER: Non-melanoma: PD-1 eligible: PD-1 and oncolytic virus: RP-001-16

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

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Malignancy

Non-melanoma skin cancer, basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

No prior PD-1

Investigational Agent

RP1, nivolumab

Drug Class

oncolytic virus (HSV), PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Replimune, Inc.

Path

Basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, basosquamous carcinoma, high-grade dermatofibroma protuberans, angiosarcoma of the skin, non-HIV-related Kaposi sarcoma, sebaceous gland carcinome, eccrine carcinomas

Key Eligibility Criteria Details
  • Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
    • Basal cell carcinoma,
    • Cutaneous squamous cell carcinoma,
    • Merkel cell carcinoma
    • Angiosarcoma of the skin
    • Eccrine carcinoma
    • high grade dermatofibroma protuberans
    • CTCL is NOT allowed
  • Must have exhausted or refused currently available therapy
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measurable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

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Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details
  • Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
    • CDK4/6 inhibitors (abemaciclib, 
    • PI3 kinase blockers (alpelisib,
    • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
    • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
    • anti ALK TKIs (ceritinib, crizotinib)
    • MEK inhibitor (combimetinib) 
    • Anti HER2 TKIs (lapatinib, tucatinib)
  • ECOG PS 0-2
  • Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
  • No diarrhea before enrolling on the study (or starting TKI)
  • No ongoing IBS or colitis
  • Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
  • No laxative use within 7 days prior to randomization
MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ROS1 fusion. Any cancer type except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • ROS1 gene fusion positivity
  • No non-small lung cancer (NSCLC)
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: PIK3CA Mutations: myTACTIC Arm B

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmB: GDC-0077 in patients with PI3K activating mutation-positive tumors

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Malignancy

Breast, Lung (NSCLC), Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

GDC-0077

Drug Class

PI3K p110 alpha inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PIK3CA mutation positive. Any malignancy except NOT CNS tumors

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No primary CNS malignancy
  • One of the following PIK3CA mutations:
    • R88Q
    • ​G106A/D/R/S/V
    • K111N/R/E
    • G118D
    • N345D/H/I/K/S/T/Y
    • C420R
    • E453A/D/G/K/Q/R/V
    • E542A/D/G/K/Q/R/V
    • E545A/D/G/K/L/Q/R/V
    • Q546E/H/L/P/R
    • M1043I/T/V
    • H1047D/I/L/M/P/Q/R/T/Y
    • G1049A/C/D/R/S
    • Others only with study medical monitor approval
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No anti-hyperglycemic medication (no treated T2DM or T1DM)
MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Not Non-small cell lung cancer (NO NSCLC)
  • ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PTEN loss or loss of function

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
  • PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No insuline dependent diabetes
MOLECULARLY TARGETED: AKT mutation: myTACTIC Arm D(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

select AKT mutations

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • One of the following mutations in AKT:
    • ​AKT 1 : E17K, L52R, or Q79K
    • AKT 2 : E17K
    • AKT 3: E17K, L51R, or Q78K
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No insulin dependent diabetes
MOLECULARLY TARGETED: TMB high: myTACTIC Arm E(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line but cannot have previously had PD-1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

TMB high, defined as > or = 10 mutations/megabase

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Tumor mutational burden-high (TMB-H) determined by CLIA opr quivalently certified assay, via tissue or blood
  • No prior treatment with anti-PD1 or anti-PD-L1 agents
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: MSI-h/dMMR: myTACTIC Arm E(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior anti-PD-1 or anti-PD-L1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

MSI-h or dMMR

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
  • No prior treatment with anti-PD1 or anti-PD-L1 agents
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: HER2/ERBB2 amplification or mutation: myTACTIC Arms F/G/H/I

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm F: Trastuzumab emtansine plus atezolizumab   Arm G: PH FDC SC  Arm H: PH FDC SC plus chemotherapy Arm I: trastuzumab emtansine plus tucatinib, in patients with ERBB2 gene amplification- or mutation-positive tumors.

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior

Investigational Agent

TDM-1 with atezolizumab, or PH FDC SC with or without chemotherapy, or TDM-1 with tucatinib

Drug Class

Anti-HER2 agents

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB2 amplification or specific mutation

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • ​TMB must be <10 mutations/megabase
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: HER2/ERBB2 amp or mut; TMB-h: myTACTIC Arm J

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

TD-M1 + atezolizumab

Drug Class

anti-HER2 agent and anti-PD-L1 agent

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB amplificaiton or mutation AND TMB-h or MSI-h or dMMR

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • Must ALSO have one of the following alterations
    • ​TMB > or =10 mutations/megabase
    • MSI-h
    • dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

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

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

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

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
    • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
  • 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
ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

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Malignancy

Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line (post standard therapy)

Investigational Agent

COM-701, BMS-986207, nivolumab

Drug Class

PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen, Ltd

Path

PVRL2 high (only for basket cohort)

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior therapy with immune therapy are eligible (except in ovarian cohort)
  • In Expansion cohorts patients must either have
    • Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
    • Advanced MSS endometrial cancer
    • A different malignancy that has high expression of PVRL2
  • No active autoimmune disease
  • No interstitial lung disease
  • No active CNS metastases
  • In ovaran cohort, no prior immunotherapy
  • No prior therapy with PVRIG inhibitor or anti-TIGIT antibody
ADVANCED SOLID TUMORS: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
  • Must not be eligible for curative resection
  • Must be positive for at least 1 of the following human leukocyte antigens:
    • HLA-A*02:01
    • HLA-A*02:06
    • HLA-A*24:02
    • HLA-A*03:01
    • HLA-B*15:01
  • ECOG PS 0-1
  • No known CNS mets
  • No known HIV/HBV/HCV
ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details
  • Advanced solid tumor or relapsed/refractory lymphoma OR
    • eligible to receive single agent pembrolizumab as standard-of-care OR
    • eligible to receive single-agent docetaxel as standard of care OR
      ​advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
  • Measurable disease
  • ECOG PS 0-1
  • No history of severe autoimmune disease
  • Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy
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