Phase 2 Completed N=61 Randomized Treatment

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

Source: ClinicalTrials.gov NCT03190265 ↗

Enrolled (actual)

Serious AEs

79.0%

Results posted

Jul 2023

Primary outcomePrimary: Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) — 0; 2 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)	0; 2	—
SECONDARY Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)	10; 10	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03190265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.