Ovarian Cancer Clinical Trial

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Summary

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) 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) and 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.

View Eligibility Criteria

Eligibility 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.

Part 2:

Arm A SCCHN:

Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).

Arm B RCC (clear cell):

1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
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.
Active or prior autoimmune disease
Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

122

Study ID:

NCT04152018

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 22 Locations for this study

See Locations Near You

Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale Arizona, 85258, United States
Virginia G. Piper Cancer Pharmacy
Scottsdale Arizona, 85258, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
UCLA Hematology/Oncology
Los Angeles California, 90095, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - North County
Saint Louis Missouri, 63136, United States
Siteman Cancer Center - St. Peters
Saint Peters Missouri, 63376, United States
Monter Cancer Center
Lake Success New York, 11042, United States
Duke Univ. Medical Center/Duke Cancer Center
Durham North Carolina, 27710, United States
Investigational Chemotherapy Service
Durham North Carolina, 27710, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
NEXT Oncology
San Antonio Texas, 78229, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
Southern Medical Day Care Centre
Wollongong New South Wales, 2500, Australia
Asan Medical Center
Seoul Seoul-teukbyeolsi [seoul], 05505, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava , 812 5, Slovakia
POKO Poprad, s.r.o., Ambulancia klinickej onkologie
Poprad , 058 0, Slovakia
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

122

Study ID:

NCT04152018

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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