Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Capecitabine

Durvalumab

Iron-Dextran Complex

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks (colorectal cancer patients only)

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

CV301

1000mg orally twice a day, Monday - Friday Weekly

Michael Pishvaian, MD PhD

This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma

The Recommended Phase II dose of durvalumab in the combination of durvalumab plus CV301 with maintenance chemotherapy as determined by the Phase I design

To determine the progression free survival (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine and bevacizumab in patients with metastatic colorectal cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

To determine the progression free survival rate (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine in patients with metastatic pancreatic cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

ORR is defined as the proportion of patients whose best overall response recorded during treatment is either CR or PR according to the RECIST version 1.1.

PFS is defined as the time from consenting to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.

To determine overall survival, subjects will be followed from time of consent until death (or until study termination). Subject will be followed for survival after discontinuing study medication and after the adverse event collection period has ended.

DCR is defined as the proportion of patients with a documented CR, PR, or SD at 4 months according to the RECIST version 1.1.

Tolerability and safety of the combination as determined by the number of patients with treatment emergent adverse events

The duration of response will also be captured as the time from which a response was first identified, until progression of disease according to the RECIST version 1.1 (or death due to any cause).

Mayo Clinic

Indiana University

Emory University

National Cancer Institute (NCI)

George Mason University

Thomas Jefferson University

MedImmune LLC

Bavarian Nordic

Georgetown University

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks (colorectal cancer patients only)

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly

Bevacizumab: 5mg/kg IV q2weeks

Phase I - Safety

Phase I - Safety- All Groups

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Benjamin Weinberg, MD

Phase 1 not completed because study terminated due to lack of enrollment. Recommended phase II dose could not be determined.

Recommended Phase II Dose of Durvalumab

Phase I - Safety- Colorectal Cancer

Progression Free Survival (PFS) Colorectal Cancer

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly

Phase I - Safety- Pancreatic Cancer

Progression Free Survival (PFS) Pancreatic Cancer

Objective Response Rate (ORR)

Phase I - Safety- Overall

Progression Free Survival (PFS)

number of subjects still alive at the end of the study follow up

Overall Survival (OS)

Disease Control Rate (DCR)

Tolerability and Safety of the Combination

Duration of Response

Phase I - Safety- Colorectal Cancer Arm

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5mL given s.c.

Capecitabine: 1000mg orally twice a day,Monday - Friday Weekly

Spots Global Cancer Trial Database for Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial