Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer
Purpose
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them. To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer. Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
Conditions
- Carcinoma, Renal Cell
- Advanced Renal Cell Carcinoma
- Renal Cancer
- Renal Neoplasm
- Clear Cell Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
- Clear-cell Metastatic Renal Cell Carcinoma
- Carcinoma, Renal Cell Metastasis
- Advanced or Metastatic Renal Cell Carcinoma
- Carcinoma, Renal Cell, Advanced
- Metastatic Renal Cell Cancer
- Metastatic Renal Cell Carcinoma ( mRCC)
- Metastatic/Advanced Renal Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years of age or older at screening - Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology - At least one measurable (as defined by the investigator) and untreated lesion - Adequate hematologic, hepatic, cardiac and renal function - No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior) - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. - All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories
Exclusion Criteria
Participants may be excluded if they meet any of the following: - Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression. - Clinically significant risk of haemorrhage or fistula - History of another malignancy within 3 years - History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. - active autoimmune diseases requiring systemic treatment within the past 2 years - uncontrolled cardiac and other comorbidities within 6 months prior to the first dose - Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study - History of severe bleeding tendency or coagulation dysfunction - History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess - Acute, chronic or symptomatic infections - Participants with history of immunodeficiency
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A |
Participants will receive PF-08634404 IV. |
|
|
Experimental Cohort B |
Participants will receive PF-08634404 in combination with drug 1. |
|
|
Experimental Cohort C |
Participants will receive PF-08634404 IV in combination with drug 2. |
|
Recruiting Locations
Fayetteville, Arkansas 72703
Rogers, Arkansas 72758
Springdale, Arkansas 72762
Duarte, California 91010
Duarte, California 91010
Irvine, California 92618
Irvine, California 92618
Long Beach, California 90813
Upland, California 91786
Denver, Colorado 80218
Zion, Illinois 60099
Burnsville, Minnesota 55337
Chaska, Minnesota 55318
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Woodbury, Minnesota 55125
Myrtle Beach, South Carolina 295724607
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Austin, Texas 78731
Austin, Texas 78758
Beaumont, Texas 77702
Houston, Texas 77024
Houston, Texas 77054
Irving, Texas 75063
Irving, Texas 75063
McAllen, Texas 78503
Pearland, Texas 77584
Sugar Land, Texas 77479
The Woodlands, Texas 77380
Webster, Texas 77598
Blacksburg, Virginia 24060
Fairfax, Virginia 22031
Low Moor, Virginia 24457
Roanoke, Virginia 24014
Salem, Virginia 24153
Wytheville, Virginia 24382
Hudson, Wisconsin 54016
More Details
- Status
- Recruiting
- Sponsor
- Pfizer