West Cancer Center

COLORECTAL: METASTATIC: 1ST LINE: BRAF MT: BREAKWATER

An open-label, multicenter, randomized Phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAF V600E-mutant colorectal cancer

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Malignancy

Colon, Rectum, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Encorafenib, cetuximab

Drug Class

BRAF inhibitor, EGFR antibody

PI

Axel Grothey, MD

Sponsor

Pfizer

Path

Key Eligibility Criteria Details

Age 16 or greater
Histologically or cytologically confirmed Stage IV CRC
Must contain a BRAF V600E mutation on local (FMI or Caris) or central testing
No prior systemic treatment in metastatic setting
Prior adjuvant or neoadjuvant therapy is OK only if relapse/metastasis is 6 months or greater from the end of the neo/adjuvant treatment
No history of acute or chronic pancreatitis
No symptomatic brain mets
Must have measurable disease

COLORECTAL: Metastatic: 1st Line Maintenance: LYNK-003

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

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Malignancy

Colon, Rectal, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Maintenance (after 1st Line)

Investigational Agent

Olaparib + Bevacizumab

Drug Class

PARP inhibitor

PI

Axel Grothey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details

Metastatic or unresectable colorectal adenocarcinoma
Has not progressed after first-line induction of at least 6 cycles of FOLFOX with bevacizumab
- May have received prior adjuvant/neoadjuvant chemo for CRC as long as it was completed at least 6 months prior to initiation of metastatic FOLFOX-bev
Has experienced unacceptable toxicity to oxaliplatin that required the discontinuation of oxaliplatin (such as neurotoxicity)
Must be randomized within a minimum of 2 weeks and a maximum of 6 weeks after their last dose of FOLFOX+bev
ECOG PS 0-1
No known CNS disease
No known HIV/HBV/HCV
No clinically significant bleeding within 28 days
No uncontrolled hypertension, nephrotic syndrome, GI perforation
No prior tx with olaparib or other PARP inhibitor

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

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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 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details

ECOG PS 0-1
No active CNS disease (controlled brain mets are allowed)
Must have one of the five malignancies below
- Clear-cell RCC
- Triple-negative Breast Cancer
- Squamous cell carcinoma of the head and neck
- Colorectal cancer
- Non-small cell lung cancer
No other malignancies within 2 years
No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
No severe autoimmune reactions to immunotherapy
No need for active steroid therapy
No significant cardiac disease
No chronic hepatitis
No active interstitial lung disease
RCC specific eligibility criteria
- Previously received one or two anti-VEGFR therapies
- No more than 3 total prior systemic tx in metastatic setting
- Must have evidence of progression on or after last treatment received and within 6 months of starting study
CRC specific eligibilty criteria
- Must have received and progressed on at least 1 standard therapy for metastatic disease
- Must have known MSI status
NSCLC specific eligibility criteria
- Must have progressed on or been refractory to platinum doublet
- Must have known EGFR, ALK, ROS1 status.
  - Those with EGFR or ALK alterations must have previously received TKI therapy
SCCHN specific eligibility criteria
- Not amenable ot local therapy with curative intent
- Must have progressed on or been intolerant of platinum containing regimen
TNBC specific eligibility criteria
- Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane

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Clinical Trials