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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT03376659
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    750mg IV q2 weeks
  • CV301 — BIOLOGICAL
    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 — DRUG
    1000mg orally twice a day, Monday - Friday Weekly
  • Bevacizumab — DRUG
    5mg/kg IV q2weeks

Study Details

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.

Key Dates

Start date
Aug 8, 2018
Status verified
Feb 2024
Primary completion
Aug 30, 2021
Completion
Aug 1, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I - Safety
    * 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)
  • Experimental: Phase II - 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 * Bevacizumab - q2weeks
  • Experimental: Phase II - Pancreatic 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

Primary Outcome Measure

Recommended Phase II Dose of Durvalumab [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-

Find similar trials in Washington D.C., DC

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DC

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