Domvanalimab for Gastrointestinal Tract Malignancies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Gastrointestinal Tract Malignancies+1 More
Domvanalimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of two different immunotherapy drugs, either alone or in combination with chemotherapy, for people with esophageal or stomach cancer that has spread and can't be removed with surgery.

Eligible Conditions
  • Gastrointestinal Tract Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Tract Malignancies

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 18 months

Month 18
Overall survival
Up to 18 months
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Objective Response Rate as measured by PD-L1 Expression Level
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Percentage of participants with anti-drug antibodies to domvanalimab
Percentage of participants with anti-drug antibodies to zimberelimab
Plasma concentration of domvanalimab
Plasma concentration of zimberelimab
Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gastrointestinal Tract Malignancies

Trial Design

3 Treatment Groups

Cohort C: Second Line or greater - Checkpoint Inhibitor Experienced Participants
1 of 3
Cohort B: Second Line or greater Checkpoint Inhibitor Naïve Participants
1 of 3
Cohort A: First Line - Treatment Naïve Participants
1 of 3
Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: Domvanalimab · No Placebo Group · Phase 2

Cohort C: Second Line or greater - Checkpoint Inhibitor Experienced ParticipantsExperimental Group · 2 Interventions: Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug
Cohort B: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Group · 2 Interventions: Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug
Cohort A: First Line - Treatment Naïve ParticipantsExperimental Group · 5 Interventions: Fluorouracil, Leucovorin, Oxaliplatin, Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11290
Leucovorin
2014
Completed Phase 4
~5460
Oxaliplatin
2003
Completed Phase 4
~4430
Zimberelimab
2018
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,006 Previous Clinical Trials
653,269 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
29 Previous Clinical Trials
5,179 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,618 Previous Clinical Trials
7,936,705 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least one target lesion per RECIST v1.1.
You have adequate organ and marrow function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.