CBL0137 + Immunotherapy for Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byAnthony Olszanski, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Fox Chase Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

Eligibility Criteria

Adults over 18 with advanced melanoma, either stage III with lymph node metastases or stage IV, who can undergo biopsies. They must have good performance status and normal organ/marrow function. Not eligible if they're on other trials, have active autoimmune diseases, previous CTLA-4 or PD1/PD-L1 treatments, unresolved diarrhea, or need immunosuppressants.

Inclusion Criteria

I am older than 18 years.

I am fully active or can carry out light work.

I have stage III or IV melanoma with lymph node metastases that can be biopsied or surgically treated.

+2 more

Exclusion Criteria

I have had diarrhea for over two weeks that hasn't improved with treatment.

I am taking medication that weakens my immune system.

You have a current autoimmune disease that is not under control.

+2 more

Participant Groups

The trial is testing CBL0137 combined with standard melanoma drugs Ipilimumab and Nivolumab. It's a phase I study to check safety and how the body responds to this mix of drugs in adults with serious melanoma that can be biopsied.

3Treatment groups

Experimental Treatment

Group I: CBL0137 (Dose level 1) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Group II: CBL0137 ( Dose level 2) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Group III: CBL0137 ( Dose level -1) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.