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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cyclophosphamide

Nivolumab

Ipilimumab

GVAX Pancreas Vaccine

CRS-207

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring CY, Cyclophosphamide, Pancreatic Vaccine, GVAX, Nivolumab, Vaccine, Ipilimumab, CRS-207, Immunotherapy, PD-1, Adenocarcinoma, Carcinoma, Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years.
Have histologically or cytologically proven adenocarcinoma of the pancreas.
Have metastatic disease.
Have disease progression.
Patients with the presence of at least one measurable lesion.
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).
ECOG performance status 0 or 1
Life expectancy of greater than 3 months.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

Known history or evidence of brain metastases.
Had surgery within the last 28 days
Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
Systemic steroids within the last 14 days
Use more than 2 g/day of acetaminophen.
Patients on immunosuppressive agents.
Patients receiving growth factors within the last 14 days
Known allergy to both penicillin and sulfa.
Severe hypersensitivity reaction to any monoclonal antibody.
Have artificial joints or implants that cannot be easily removed
Have any evidence of clinical or radiographic ascites.
Have significant and/or malignant pleural effusion
Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
Infection with HIV or hepatitis B or C at screening
Significant heart disease
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Are pregnant or breastfeeding.
Have rapidly progressing disease

Sites / Locations

Johns Hopkins SKCCC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207

Arm B: Nivolumab, Ipilimumab, CRS-207

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

Secondary Outcome Measures

Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.

Full Information

NCT ID

NCT03190265

First Posted

June 15, 2017

Last Updated

August 29, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Aduro Biotech, Inc., Bristol-Myers Squibb, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03190265

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

December 14, 2017 (Actual)

Primary Completion Date

August 3, 2022 (Actual)

Study Completion Date

August 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Aduro Biotech, Inc., Bristol-Myers Squibb, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

CY, Cyclophosphamide, Pancreatic Vaccine, GVAX, Nivolumab, Vaccine, Ipilimumab, CRS-207, Immunotherapy, PD-1, Adenocarcinoma, Carcinoma, Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207

Arm Type

Experimental

Arm Title

Arm B: Nivolumab, Ipilimumab, CRS-207

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

anti-PD-1, OPDIVO

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

YERVOY®

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.

Intervention Type

Drug

Intervention Name(s)

GVAX Pancreas Vaccine

Other Intervention Name(s)

GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.

Intervention Type

Drug

Intervention Name(s)

CRS-207

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.

Intervention Type

Drug

Intervention Name(s)

CRS-207

Intervention Description

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)

Description

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)

Description

Time Frame

21 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years. Have histologically or cytologically proven adenocarcinoma of the pancreas. Have metastatic disease. Have disease progression. Patients with the presence of at least one measurable lesion. 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). ECOG performance status 0 or 1 Life expectancy of greater than 3 months. Patients must have adequate organ and marrow function defined by study-specified laboratory tests. Must use acceptable form of birth control while on study. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Known history or evidence of brain metastases. Had surgery within the last 28 days Had chemotherapy, radiation, or biological cancer therapy within the last 14 days Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4 Systemic steroids within the last 14 days Use more than 2 g/day of acetaminophen. Patients on immunosuppressive agents. Patients receiving growth factors within the last 14 days Known allergy to both penicillin and sulfa. Severe hypersensitivity reaction to any monoclonal antibody. Have artificial joints or implants that cannot be easily removed Have any evidence of clinical or radiographic ascites. Have significant and/or malignant pleural effusion Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment Infection with HIV or hepatitis B or C at screening Significant heart disease Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures Are pregnant or breastfeeding. Have rapidly progressing disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dung Le, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins SKCCC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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