Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | November 13, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Primary Outcome 1 - Time Frame: Baseline up to 28 Days (Cycle 1)
Primary Outcome 2 - Measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Primary Outcome 2 - Time Frame: Baseline up to approximately 24 months
Primary Outcome 3 - Measure: Number of Participants With Adverse Events (AEs) According to Severity
Primary Outcome 3 - Time Frame: Baseline up to approximately 24 months
Primary Outcome 4 - Measure: Number of Participants With Adverse Events (AEs) According to Seriousness
Primary Outcome 4 - Time Frame: Baseline up to up to approximately 24 months
Primary Outcome 5 - Measure: Number of Participants With Adverse Events (AEs) by Relationship
Primary Outcome 5 - Time Frame: Baseline up to approximately 24 months
Primary Outcome 6 - Measure: Progression-Free Survival (PFS) for Dose Expansion
Primary Outcome 6 - Time Frame: Baseline up to 24 Months
Primary Outcome 7 - Measure: Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
Primary Outcome 7 - Time Frame: Baseline up to 24 months
Primary Outcome 8 - Measure: Duration of Response (DR) for Dose Expansion
Primary Outcome 8 - Time Frame: Baseline up to 24 Months
Criteria:
Inclusion Criteria:
- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell),
ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and
biliary duct, endometrial, melanoma, or urothelial cancer.
- Adequate bone marrow, kidney and liver function.
- Performance status of 0 or 1.
Exclusion Criteria:
- Participant disease status is suitable for local therapy administered with curative
intent.
- Hypertension that cannot be controlled by medications.
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Pfizer CT.gov Call Center
Role: Study Director
Affiliation: Pfizer
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Link: To obtain contact information for a study center near you, click here.
Facility | Status | Contact |
---|---|---|
Scottsdale Healthcare Hospitals DBA HonorHealth Scottsdale, Arizona 85258 United States |
Recruiting | |
Virginia G. Piper Cancer Pharmacy Scottsdale, Arizona 85258 United States |
Recruiting | |
Ronald Reagan UCLA Medical Center Los Angeles, California 90095 United States |
Not yet recruiting | |
UCLA Hematology Oncology Los Angeles, California 90095 United States |
Not yet recruiting | |
UCLA Hematology/Oncology Los Angeles, California 90095 United States |
Not yet recruiting | |
Siteman Cancer Center - West County Creve Coeur, Missouri 63141 United States |
Recruiting | |
Barnes-Jewish Hospital Saint Louis, Missouri 63110 United States |
Recruiting | |
Washington University School of Medicine Siteman Cancer Center Saint Louis, Missouri 63110 United States |
Recruiting | |
Siteman Cancer Center - South County Saint Louis, Missouri 63129 United States |
Recruiting | |
Siteman Cancer Center - North County Saint Louis, Missouri 63136 United States |
Recruiting | |
Siteman Cancer Center - St. Peters Saint Peters, Missouri 63376 United States |
Recruiting | |
The University of Texas MD Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting | |
NEXT Oncology San Antonio, Texas 78229 United States |
Recruiting | |
University of Washington Medical Center Seattle, Washington 98195 United States |
Recruiting |