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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding

Primary Outcome 1 - Timeframe: 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 - Timeframe: Baseline up to approximately 24 months

Primary Outcome 3 - Measure: Number of Participants With Adverse Events (AEs) According to Severity

Primary Outcome 3 - Timeframe: Baseline up to approximately 24 months

Primary Outcome 4 - Measure: Number of Participants With Adverse Events (AEs) According to Seriousness

Primary Outcome 4 - Timeframe: Baseline up to up to approximately 24 months

Primary Outcome 5 - Measure: Number of Participants With Adverse Events (AEs) by Relationship

Primary Outcome 5 - Timeframe: Baseline up to approximately 24 months

Primary Outcome 6 - Measure: Progression-Free Survival (PFS) for Dose Expansion

Primary Outcome 6 - Timeframe: Baseline up to 24 Months

Primary Outcome 7 - Measure: Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion

Primary Outcome 7 - Timeframe: Baseline up to 24 months

Primary Outcome 8 - Measure: Duration of Response (DR) for Dose Expansion

Primary Outcome 8 - Timeframe: Baseline up to 24 Months

CONDITION

• Squamous Cell Carcinoma of the Head and Neck
• Renal Cell Carcinoma
• Ovarian Cancer
• Gastric Cancer
• Esophageal Cancer
• Lung Squamous Cell Carcinoma
• Pancreatic Cancer
• Bile Duct Cancer
• Endometrial Cancer
• Melanoma Cancer
• Urothelial Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION