Clinical trialPhase 2Terminated

Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer

A Phase 2 Study of Pembrolizumab in Combination With Pelareorep in Patients With Advanced Pancreatic Adenocarcinoma

NCT03723915 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped earlyThe total accrual goal of 34 patients was not met. Stage 1 of the study did not meet the interim analysis criteria to move onto Stage 2 of the Simon 2 stage design. (Enrollment)
Phase: Phase 2
Status: Terminated
Study type: Interventional
Start: 14 November 2018
Expected end: 24 April 2021
Enrollment: 17 participants
Sites: 1
Primary outcomes: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Sponsor: Other
Results posted: 2021-01-20
Last update: 5 October 2022

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Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies the side effects and how well pembrolizumab in combination with pelareorep work in treating patients with pancreatic cancer that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. A virus, called reovirus (pelareorep), which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving pembrolizumab in combination with pelareorep may work better in treating patients with advanced pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria of pembrolizumab in combination with Reovirus Serotype 3 ? Dearing Strain (pelareorep). SECONDARY OBJECTIVES: I. To determine progression free survival by RECIST v 1.1 criteria, as well as 1- year, 2-year and median overall survival with pembrolizumab in combination with pelareorep. II. To determine safety and tolerability of pembrolizumab and pelareorep when administered in combination as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. III. To determine the effects (immune response) of pembrolizumab and pelareorep when administered in combination as determined by analysis of pre-and post-treatment biopsies and blood-based immune markers. EXPLORATORY OBJECTIVES: I. To measure the overall response rate (ORR) by using Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria, for the combination of pembrolizumab and pelareorep. II. To determine progression free survival by iRECIST criteria as well as 1-year, 2-year and median overall survival with pembrolizumab in combination with pelareorep. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 32 courses in the absence of disease progression, unacceptable toxicity, development of an inter-current illness that prevents further administration of treatment, patient decides to withdraw, patients not experiencing clinical benefit in the judgment of the Investigator, or the treating investigator determines that the patient should be taken off treatment for any reason. Patients also receive Pelareorep IV over 60 minutes on days 1, 2, 3, and 8 in course 1 and on days 1 and 8 of subsequent courses. Courses repeat every 21 days for up to 24 months in the absence of disease progression, unacceptable toxicity, development of an inter-current illness that prevents further administration of treatment, patient decides to withdraw, patients not experiencing clinical benefit in the judgment of the Investigator, or the treating investigator determines that the patient should be taken off treatment for any reason. Patients who stop study therapy with stable disease (SD) or better may be eligible for up to 1 year of additional Pelareorep and pembrolizumab therapy if they progress after stopping study treatment. After completion of study treatment, patients are followed up every 3 months for 2 years.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [Last week of Cycle 3 (1 Cycle = 21 days)]. Number, participants. Complete response: Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50 (n=12): 0. Partial response: Pembrolizumab 200 mg IV + Pelareorep 4.5x10^10 TCID_50 (n=12): 1.