Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004

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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03050814
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Avelumab — DRUG
    10 mg/kg intravenous (IV) over 30-60 min on Day 1
  • Ad-CEA vaccine — BIOLOGICAL
    Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.
  • Bevacizumab — DRUG
    5mg/kg intravenous (IV) over 30-90 min on day 1 (Arm A) or 2 (Arm B). Part of the standard of care therapy.
  • 5-Fluorouracil (FU) — DRUG
    400mg/m\^2 (only Arm A) intravenous (IV) bolus on day 1. Part of the standard of care therapy.
  • Leucovorin — DRUG
    400mg/m\^2 intravenous (IV) over 2 hours on day 1 (Arm A) or Day 2 (Arm B). Part of the standard of care therapy.
  • Oxaliplatin — DRUG
    85mg/m\^2 (Arm A) or 68mg/m\^2 (Arm B) intravenous (IV) over 2 hours on day 1 (Arm A) or Day 2 (Arm B). Part of the standard of care therapy.
  • Capecitabine — DRUG
    625 mg/m\^2 twice a day by mouth. Part of the standard of care therapy.
  • 5-Fluorouracil (FU) — DRUG
    2400 mg/m\^2 (Arm A and B) intravenous (IV) over 46 hours (+/-2 hours) to start on Day 1 (ARM A) or Day 2 (Arm B). Part of the standard of care therapy.

Study Details

Background: Colorectal cancer is a common cancer in the Unites States (U.S.) It causes the second most cancer-related deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer. Objective: To test if avelumab and Ad-CEA plus standard therapy treats colorectal cancer that has spread to other sites better than standard therapy alone. Eligibility: People ages 18 and older with untreated colorectal cancer that has spread in the body Design: Participants will be screened with: Test to see if their cancer has a certain deficiency Blood, urine, and heart tests Scans Medical history Physical exam Tumor sample. This can be from a previous procedure. A small group of participants will get Ad-CEA and avelumab plus standard therapy. This is leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) plus bevacizumab for up to 24 weeks then capecitabine plus bevacizumab. The others will have treatment in 2-week cycles. They will be Arm A or B: Arm A: FOLFOX and bevacizumab by intravenous (IV) days 1 and 2 for 12 cycles. After that, capecitabine by mouth twice a day and bevacizumab by IV on day 1. Arm B: Ad-CEA injection every 2-12 weeks. Avelumab by IV on day 1 of each cycle. FOLFOX and bevacizumab by IV days 2 and 3 for 12 cycles. Then, capecitabine by mouth twice a day and bevacizumab through IV on day 2. Participants will repeat screening tests during the study. Participants will be treated until their disease gets worse or they have bad side effects. Arm A participants can join Arm B. They will have a visit 4 5 weeks after they stop therapy.

Key Dates

First listed
Feb 13, 2017
Start date
Apr 5, 2017
Status verified
Dec 2021
Primary completion
Aug 25, 2021
Completion
Aug 25, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (SOC) - Arm A
    Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine until disease progression.
  • Experimental: Standard of Care (SOC) - Arm B + Lead in
    Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + avelumab + Ad-CEA vaccine (given weeks 0,2,4,8,12,16 and then every 12 weeks) for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine + avelumab + Ad-CEA vaccine (following the every 12-week dosing schedule) until disease progression.

Primary Outcome Measure

Progression Free Survival Between the Standard of Care (SOC) Arm A, and Standard of Care (SOC) Arm B + lead-in [ Time Frame: Up to 1.5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Washington D.C., DC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCNational Institutes of Health Clinical Center· Bethesda, MD

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