West Cancer Center

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

VIEW TRIAL ON CLINICALTRIALS.GOV

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.

VIEW TRIAL ON CLINICALTRIALS.GOV

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.

VIEW TRIAL ON CLINICALTRIALS.GOV

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

VIEW TRIAL ON CLINICALTRIALS.GOV

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.

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

VIEW TRIAL ON CLINICALTRIALS.GOV

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.

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV

Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets