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~5 spots leftby Mar 2026

APX005M + Nivolumab + Cabiralizumab for Melanoma

Recruiting in Palo Alto (17 mi)

Overseen ByHarriet Kluger, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Yale University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab. The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6 cohorts to determine the recommended phase II dose (RP2D) of APX005M. The phase 1b dose expansion portion will study the triple drug combination separately in the three disease cohorts: melanoma, NSCLC, and RCC.

Eligibility Criteria

Adults with advanced melanoma, NSCLC, or RCC who have measurable lesions and normal organ/marrow function. They must not be pregnant, agree to contraception use, and can't have untreated brain metastases or certain active infections. Prior treatments should be completed within specific timeframes before starting the study drugs.

Inclusion Criteria

My kidney cancer is advanced, cannot be surgically removed, or has spread.

My melanoma, NSCLC, or RCC has worsened after treatment with a PD-1 or PD-L1 inhibitor.

I can provide tissue samples from at least one cancer site.

My organs and bone marrow are functioning normally.

I have a tumor that can be measured by CT or MRI.

I can do most of my daily activities without help.

I have advanced melanoma that cannot be surgically removed.

Exclusion Criteria

I don't have muscle disorders or recent muscle injuries that affect my CK levels.

I haven't had immune therapy or chemotherapy in the last 4 weeks and have recovered from any side effects.

I have been treated with CSF1R inhibitors or CD40 agonists before.

I have brain metastases that have not been treated.

I've had severe nerve, heart, or liver side effects from previous cancer immunotherapy.

My cancer has spread to the lining of my brain and spinal cord.

I have other active cancers besides the one being studied.

I have HIV, HBV, or HCV infection.

I do not have any open wounds or active skin infections.

I am currently taking statins.

I have lung inflammation that is not caused by an infection.

I have uveal melanoma.

I am not currently in any other clinical trials or have been in one within the last 4 weeks.

Participant Groups

The trial is testing a combination of three drugs: APX005M, Nivolumab, and Cabiralizumab in patients with advanced solid tumors. It includes an initial phase to find the best dose followed by a second phase focusing on each cancer type separately.

9Treatment groups

Experimental Treatment

Group I: Cohort 9 RCCExperimental Treatment3 Interventions

Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.

Group II: Cohort 8 NSCLCExperimental Treatment2 Interventions

Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.

Group III: Cohort 7 Advanced MelanomaExperimental Treatment3 Interventions

Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.

Group IV: Cohort 6 Advanced Solid TumorsExperimental Treatment3 Interventions

Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.

Group V: Cohort 5 Advanced Solid TumorsExperimental Treatment2 Interventions

Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.

Group VI: Cohort 4 Advanced Solid TumorsExperimental Treatment3 Interventions

Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.

Group VII: Cohort 3 Advanced Solid TumorsExperimental Treatment2 Interventions

Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.

Group VIII: Cohort 2 Advanced Solid TumorsExperimental Treatment3 Interventions

Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.

Group IX: Cohort 1 Advanced Solid TumorsExperimental Treatment2 Interventions

Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.