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Cancer Vaccine

Durvalumab for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining two drugs, durvalumab and CV301, with maintenance chemotherapy. The goal is to evaluate the safety and activity of this new combination therapy in patients with metastatic colorectal or pancreatic cancer.

Eligible Conditions

Colorectal Cancer
Pancreatic Adenocarcinoma
Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) Colorectal Cancer

Progression Free Survival (PFS) Pancreatic Cancer

Recommended Phase II Dose of Durvalumab

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response

Objective Response Rate (ORR)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase II - Pancreatic Cancer ArmExperimental Treatment3 Interventions

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

Group II: Phase II - Colorectal Cancer ArmExperimental Treatment4 Interventions

Group III: Phase I - SafetyExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

CV301

2016

Completed Phase 2

~70

Capecitabine

2013

Completed Phase 3

~3420

Bevacizumab

2013

Completed Phase 4

~5280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedImmune LLCIndustry Sponsor

347 Previous Clinical Trials

793,901 Total Patients Enrolled

Indiana UniversityOTHER

980 Previous Clinical Trials

983,153 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,659 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what ailment is CV301 most often recommended?

"CV301 is most often used to fight recurrent platinum-resistant ovarian cancer in epithelial cells. However, it has also been taken as a treatment for malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

What other medical studies have there been with CV301?

"As of now, 1008 clinical trials are being conducted to research CV301. 265 of those live studies are in the final stage, Phase 3. However, these many studies for CV301 aren't limited to Guangzhou, Guangdong; there are 42608 locations running trials for this treatment worldwide."

Answered by AI

Are enrollees still being sought for this particular clinical trial?

"According to the latest information available on clinicaltrials.gov, this particular trial has completed patient recruitment. The trial was originally posted on 8/8/2018 and was last updated on 3/15/2022. There are 2028 other trials that are still recruiting patients."

Answered by AI

What is the main goal of this clinical trial?

"The success of this study will be determined by the 8.5 month progression free survival rate (PFS8.5mos), which will be measured over a 6-month period. Additionally, objective response rate (ORR), duration of response, and progression free survival (PFS) will be monitored as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03376659.