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Monoclonal Antibodies

Zimberelimab + Domvanalimab for Melanoma

Phase 2

Recruiting

Led By Diwakar Davar, MD

Research Sponsored by Diwakar Davar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have progressed on treatment with an anti-PD-1/L1 mAb

Male participants must agree to use contraception during treatment period and refrain from donating sperm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see how well it works in patients with melanoma that has not responded to other treatments.

Who is the study for?

This trial is for adults with a confirmed diagnosis of cutaneous melanoma who have previously not responded to anti-PD-1/L1 mAb treatments. They must have measurable disease, be able to provide a biopsy, and have good organ function and performance status. Women can't be pregnant or breastfeeding and must use contraception; men also need to use contraception.Check my eligibility

What is being tested?

The study tests the combination of Zimberelimab (AB122) with Domvanalimab (AB154) in patients whose melanoma has not improved after PD-1 inhibitor therapy. The main goal is to see how many patients experience a reduction in their cancer size as a response to this treatment combo.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to the immune system, such as inflammation in various organs, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened despite treatment with an anti-PD-1/L1 medication.

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I agree to use contraception and not donate sperm during the treatment.

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I can provide a recent biopsy of my tumor that hasn't been treated with radiation.

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I am 18 or older with a confirmed diagnosis of skin melanoma.

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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

1-year Overall Survival (OS)

1-year Progression-free Survival (PFS)

2-year Overall Survival (OS)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zimberelimab plus DomvanalimabExperimental Treatment2 Interventions

Treatment Phase 1: Zimberelimab, 360mg, IV, every 3 weeks for 3 cycles. Domvanalimab, 15mg/kg, IV, every 3 weeks for 3 cycles. After 3 cycles, scans will be performed. If it is determined that the cancer is stable or responding patients will continue with Treatment Phase 2. Treatment Phase 2: Zimberelimab, 360mg, IV, every 3 weeks for 3 cycles. Domvanalimab, 15mg/kg, IV, every 3 weeks, for up to 24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2018

Completed Phase 1

~50

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

6,040 Total Patients Enrolled

2 Trials studying Melanoma

142 Patients Enrolled for Melanoma

Diwakar DavarLead Sponsor

10 Previous Clinical Trials

385 Total Patients Enrolled

8 Trials studying Melanoma

329 Patients Enrolled for Melanoma

Diwakar Davar, MDPrincipal InvestigatorUPMC Hillman Cancer Center

7 Previous Clinical Trials

237 Total Patients Enrolled

6 Trials studying Melanoma

211 Patients Enrolled for Melanoma

Media Library

Domvanalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05130177 — Phase 2

Melanoma Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT05130177 — Phase 2

Domvanalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130177 — Phase 2

Melanoma Research Study Groups: Zimberelimab plus Domvanalimab

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Zimberelimab gone through the necessary regulatory steps to be cleared by the FDA?

"Zimberelimab's safety was assigned a score of 2 on the scale since it is in Phase 2, meaning that there are some data points ensuring its security but none attesting to its efficacy."

Answered by AI

Is this experiment open to new participants at the moment?

"Data posted on clinicaltrials.gov verifies that this experiment is actively recruiting test subjects, with the original posting of 3/16/2022 and the most recent revision made on 4/11/2022."

Answered by AI

Could you provide the exact figure for participants enrolled in this trial?

"Affirmative. Clinicaltrials.gov shows that the research, which was first advertised on March 16th 2022, is actively recruiting participants. 26 patients need to be recruited from one site for this investigation into a novel treatment option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

Diwakar Davar 2022. "Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130177.