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Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

NCT03190265•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years.
•2. Have histologically or cytologically proven adenocarcinoma of the pancreas.
•3. Have metastatic disease.
•4. Have disease progression.
•5. Patients with the presence of at least one measurable lesion.
•6. Patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
•7. ECOG performance status 0 or 1
•8. Life expectancy of greater than 3 months.
•9. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
•10. Must use acceptable form of birth control while on study.
+1 more criteria

Exclusion Criteria

•1. Known history or evidence of brain metastases.
•2. Had surgery within the last 28 days
•3. Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
•4. Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
•5. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
•6. Systemic steroids within the last 14 days
•7. Use more than 2 g/day of acetaminophen.
•8. Patients on immunosuppressive agents.
•9. Patients receiving growth factors within the last 14 days
•10. Known allergy to both penicillin and sulfa.
+10 more criteria

Locations (1)

Johns Hopkins SKCCC

Baltimore, Maryland, United States

Key Dates

Start Date

December 14, 2017

Primary Completion Date

August 3, 2022

Completion Date

August 23, 2023

Last Updated

August 7, 2024

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Cyclophosphamide

DRUG

Nivolumab

DRUG

Ipilimumab

DRUG

GVAX Pancreas Vaccine

DRUG

CRS-207

DRUG

CRS-207

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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