Clinical trialPhase 1 / Phase 2Terminated
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
- Outcome
- Stopped earlyStudy closed due to lack of enrollment. (Enrollment)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 8 August 2018
- Expected end
- 1 August 2023
- Enrollment
- 8 participants
- Sites
- 1
- Primary outcomes
- Recommended Phase II Dose of Durvalumab; Progression Free Survival (PFS) Colorectal Cancer; Progression Free Survival (PFS) Pancreatic Cancer
- Sponsor
- Other
- Results posted
- 2023-01-10
- Last update
- 5 February 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Recommended Phase II Dose of Durvalumab [6 months].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) Colorectal Cancer [24 months]. Median, months (Full Range). Phase I - Safety- Colorectal Cancer (n=4): 7.4 (3.2 to 12.9).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) Pancreatic Cancer [24 months]. Median, months (Full Range). Phase I - Safety- Pancreatic Cancer (n=4): 4.5 (2.8 to 7.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [1 year]. Count Of Participants, Participants. Phase I - Safety- All Groups (n=8): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [24 months]. Median, months (Full Range). Phase I - Safety- Overall (n=8): 4.7 (2.8 to 12.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [4 years]. Count Of Participants, Participants. Phase I - Safety- All Groups (n=8): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) [4 months]. Count Of Participants, Participants. Phase I - Safety- All Groups (n=8): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tolerability and Safety of the Combination [2 years]. Count Of Participants, Participants. Phase I - Safety- All Groups (n=8): 8.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response [1 year]. Mean, days (Full Range). Phase I - Safety- All Groups (n=8): 145 (59 to 172).