Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
Purpose
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: - Be 18 years or older. - Have colorectal cancer that has spread to other parts of your body. - Be in good enough health to receive study treatment. - Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. - The study is expected to last approximately 33 months for each participant. - Participants will have regular visits to the study site for treatment, health checks, and tests. - After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. - Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
Conditions
- Intestinal Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Neoplasms by Site
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Colorectal Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histological or cytological confirmed colorectal adenocarcinoma. - Evidence of Stage IV metastatic disease. - No prior systemic therapy for metastatic disease. - Eastern Cooperative Oncology Group performance status (ECOG) 0-1 - At least one measurable lesion according to RECIST 1.1 per Investigator assessment. - Adequate hepatic, liver, and renal function
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: - Locally confirmed BRAF V600E mutation - Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer - Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression - Clinically significant risk of hemorrhage or fistula - Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study - History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation - Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events - Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose - Participants with active autoimmune diseases requiring systemic treatment within the past 2 years - Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PF-08634404 + Chemotherapy |
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy. |
|
|
Active Comparator Bevacizumab + Chemotherapy |
Participants will receive bevacizumab IV in combination with Chemotherapy. |
|
Recruiting Locations
Chandler, Arizona 85224
Gilbert, Arizona 85297
Glendale, Arizona 85306
Goodyear, Arizona 85395
Mesa, Arizona 85202
Mesa, Arizona 85206
Phoenix, Arizona 85028
Scottsdale, Arizona 85260
Fayetteville, Arkansas 72703
Rogers, Arkansas 72758
Springdale, Arkansas 72762
Berkeley, California 94702
San Francisco, California 94107
San Francisco, California 94115
San Francisco, California 94143
San Francisco, California 94158
Aurora, Colorado 80012
Boulder, Colorado 80303
Centennial, Colorado 80112
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Englewood, Colorado 80113
Lakewood, Colorado 80228
Littleton, Colorado 80120
Lone Tree, Colorado 80124
Longmont, Colorado 80504
Pueblo, Colorado 81003
Thornton, Colorado 80260
Bonita Springs, Florida 34135
Bradenton, Florida 34211
Brandon, Florida 33511
Cape Coral, Florida 33909
Coral Springs, Florida 33065
Fort Myers, Florida 33905
Fort Myers, Florida 33908
Largo, Florida 33770
Melbourne, Florida 32935
N. Venice, Florida 34275
Naples, Florida 34102
Orange City, Florida 32763
Palm Bay, Florida 32909
Palm Harbor, Florida 34683
Port Charlotte, Florida 33980
Rockledge, Florida 32955
Sarasota, Florida 34236
St. Petersburg, Florida 33701
St. Petersburg, Florida 33709
Trinity, Florida 34655
Athens, Georgia 30607
Boise, Idaho 83706
Nampa, Idaho 83687
Arlington Heights, Illinois 60005
Bloomington, Illinois 61704
Chicago, Illinois 60631
Galesburg, Illinois 61401
Hinsdale, Illinois 60521
New Lenox, Illinois 60451
Niles, Illinois 60714
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peru, Illinois 61354
Washington, Illinois 61571
Indianapolis, Indiana 46237
Mooresville, Indiana 46158
Topsham, Maine 04086
Westbrook, Maine 04092
Baltimore, Maryland 21204
Boston, Massachusetts 02115
Boston, Massachusetts 02215
Milford, Massachusetts 01757
Newton, Massachusetts 02467
Big Rapids, Michigan 49307
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49546
Holland, Michigan 49424
Norton Shores, Michigan 49444
Marshall, Minnesota 56258
Lincoln, Nebraska 68516
Reno, Nevada 89502
Reno, Nevada 89502
Albany, New York 12206
Auburn, New York 13021
Babylon, New York 11702
Brooklyn, New York 11210
Camillus, New York 13031
Clifton Park, New York 12065
East Syracuse, New York 13057
New Hyde Park, New York 11042
New York, New York 10028
Nyack, New York 10960
Patchogue, New York 11772
Port Jefferson Station, New York 11776
Riverhead, New York 11901
Shirley, New York 11967
The Bronx, New York 10469
Cary, North Carolina 27518
Durham, North Carolina 27710
Durham, North Carolina 27710
Durham, North Carolina 27710
Raleigh, North Carolina 27609
Cincinnati, Ohio 45245
Cleveland, Ohio 44106
Fairfield, Ohio 45014
Albany, Oregon 97321
Clackamas, Oregon 97015
Corvallis, Oregon 97330
Eugene, Oregon 97401
Hillsboro, Oregon 97124
Portland, Oregon 97227
Springfield, Oregon 97477
Aberdeen, South Dakota 57401
Mitchell, South Dakota 57301
Pierre, South Dakota 57501
Sioux Falls, South Dakota 57105
Yankton, South Dakota 57078
Nashville, Tennessee 37232
Abilene, Texas 79606
Amarillo, Texas 79124
Beaumont, Texas 77702
Denison, Texas 75020
Denton, Texas 76201
El Paso, Texas 79902
El Paso, Texas 79915
El Paso, Texas 79938
Flower Mound, Texas 75028
Houston, Texas 77008
Houston, Texas 77024
Houston, Texas 77024
Houston, Texas 77030
Houston, Texas 77054
Houston, Texas 77070
Houston, Texas 77098
Humble, Texas 77338
Irving, Texas 75063
Irving, Texas 75063
Longview, Texas 75601
Midland, Texas 79701
Odessa, Texas 79761
Pearland, Texas 77584
Sugar Land, Texas 77479
The Woodlands, Texas 77380
Tyler, Texas 75702
Wichita Falls, Texas 76310
Arlington, Virginia 22201
Blacksburg, Virginia 24060
Fairfax, Virginia 22031
Low Moor, Virginia 24457
Manassas, Virginia 20110
Mechanicsville, Virginia 23116
Midlothian, Virginia 23112
Petersburg, Virginia 23805
Reston, Virginia 20190
Richmond, Virginia 23229
Richmond, Virginia 23235
Roanoke, Virginia 24014
Salem, Virginia 24153
Woodbridge, Virginia 22191
Wytheville, Virginia 24382
Bonney Lake, Washington 98391
Federal Way, Washington 98003
Gig Harbor, Washington 98332
Puyallup, Washington 98373
Seattle, Washington 98109
Seattle, Washington 98195
Tacoma, Washington 98405
Mayagüez, Puerto Rico 00680
Rio Piedras, Puerto Rico 00935
San Juan, Puerto Rico 00907
San Juan, Puerto Rico 00909
More Details
- Status
- Recruiting
- Sponsor
- Pfizer