DOMVANALIMAB for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Cancer+3 MoreDOMVANALIMAB - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being done to see if it is safe and effective to use these immunotherapy drugs together to treat patients with pancreatic cancer that has spread to other parts of the body.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • Pancreatic Adenosquamous Carcinoma
  • Pancreatic Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Treatment Arm

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Every 8 weeks up to 38 Months

28 Days
Dose-limiting toxicities-Phase 1
Month 38
Duration of Response (DoR)
Month 38
Disease Control Rate
Objective Response Rate (ORR)
Up to 38 Months
Number of Participants With Treatment-Related Adverse Events
Month 38
Overall Survival
Progression Free Survival
Switch Maintenance-Progression Free Survival

Trial Safety

Safety Progress

1 of 3

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1
Patient Navigation Program
1
Cancer Survivorship Leadership Training for Clergy Wives and Widows
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Treatment Arm

Trial Design

4 Treatment Groups

ARM B: FOLFIRI
1 of 4
CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M
1 of 4
LEAD-IN: DOSE DE-ESCALATION
1 of 4
ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M
1 of 4

Active Control

Experimental Treatment

46 Total Participants · 4 Treatment Groups

Primary Treatment: DOMVANALIMAB · No Placebo Group · Phase 1 & 2

CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005MExperimental Group · 3 Interventions: DOMVANALIMAB, APX005M, ZIMBERELIMAB · Intervention Types: Drug, Drug, Drug
LEAD-IN: DOSE DE-ESCALATIONExperimental Group · 3 Interventions: DOMVANALIMAB, APX005M, ZIMBERELIMAB · Intervention Types: Drug, Drug, Drug
ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005MExperimental Group · 3 Interventions: DOMVANALIMAB, APX005M, ZIMBERELIMAB · Intervention Types: Drug, Drug, Drug
ARM B: FOLFIRI
Drug
ActiveComparator Group · 1 Intervention: FOLFIRI · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APX005M
2017
Completed Phase 2
~320

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks up to 38 months

Who is running the clinical trial?

James Cleary, MD, PhDLead Sponsor
1 Previous Clinical Trials
Lustgarten FoundationOTHER
20 Previous Clinical Trials
2,349 Total Patients Enrolled
Arcus Biosciences, Inc.Industry Sponsor
31 Previous Clinical Trials
5,636 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a total bilirubin level of ≤ 1.5 x institutional upper limit of normal (ULN) or a total bilirubin level of ≤ 3 x ULN.
You have histologically confirmed pancreatic cancer that is metastatic and for which standard curative or palliative measures do not exist or are no longer effective
You have a platelet count of at least 100,000/mcL.
References

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