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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004009-29 | EudraCT Number |
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Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.
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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 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Single Agent Dose Escalation |
|
| Dose Finding Anti-PD-1 Combination 1 | Experimental | Part 1B PF-06940434 plus anti-PD-1 |
|
| Dose Expansion Arm A | Experimental | PF-06940434 with anti-PD-1 in SCCHN |
|
| Dose Expansion Arm B | Experimental | PF-06940434 with anti-PD-1 in RCC |
|
| Dose Expansion, Arm C | Experimental | PF-06940434 with anti-PD-1 (both Q3W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06940434 | Drug | PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding | Baseline up to 28 Days (Cycle 1) | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Baseline up to approximately 24 months | |
| Number of Participants With Adverse Events (AEs) According to Severity | Baseline up to approximately 24 months | |
| Number of Participants With Adverse Events (AEs) According to Seriousness | Baseline up to up to approximately 24 months | |
| Number of Participants With Adverse Events (AEs) by Relationship | Baseline up to approximately 24 months | |
| Progression-Free Survival (PFS) for Dose Expansion | The period from study entry until disease progression, death or date of last contact. | Baseline up to 24 Months |
| Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion | Baseline up to 24 months | |
| Duration of Response (DR) for Dose Expansion | Baseline up to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| PF-06940434 after multiple doses PK parameters (Cmax). | Maximum observed plasma concentration of PF-06940434. | Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
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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:
Arm B RCC (clear cell):
Adequate bone marrow, kidney and liver function.
Performance status of 0 or 1.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| HonorHealth Scottsdale Shea Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| PF-06801591 | Drug | PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle. |
|
|
| Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434. |
Time zero extrapolated to the last quantifiable time point prior to the next dose. |
| Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
| Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
| Volume of Distribution (Vd) | Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
| Incidence and titers of anti-drug antibodies (ADA) against PF-06940434. | Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
| Incidence and titers of neutralizing antibodies (NAb) against PF-06940434. | Titers of neutralizing antibodies (NAb) against PF-06940434. | Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days). |
| PK parameters of PF-06940434 and PF-06801591 (Cmax). | Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591). | Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days) |
| Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591. | Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591. | Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days) |
| Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591. | Maximum observed plasma concentration of PF-06940434. | Cycle 4 Day 1 (each cycle is 28 days) |
| Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434. | Time zero extrapolated to the last quantifiable time point prior to the next dose. | Cycle 4 Day 1 (each cycle is 28 days) |
| Number of participants with increased T-cells after PF-06940434 treatment. | Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days) |
| Progression-Free Survival (PFS) for Dose Expansion | The period from study entry until disease progression, death or date of last contact. | Baseline to measured progression (up to approximately 24 months) |
| Duration of Response (DR) | Baseline up to approximately 24 Months |
| Number of Participants With Objective Response for Dose Expansion portion | Baseline up to 24 months |
| Disease Control Rate (DCR) | DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1. | Every 8 weeks from the time of enrollment up to 2 years |
| Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion | Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days) |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days] |
| Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion | Incidence and titers of anti-drug antibodies (ADA) against PF-06801591. | Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]. |
| Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion. | Incidence and titers of neutralizing antibodies (NAb) against PF-06801591. | Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]. |
| Overall Survival | The period from study entry until death or date of last contact (24 months) | From baseline to up to 2 years after last dose of study drug |
| Scottsdale |
| Arizona |
| 85260 |
| 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 | Santa Monica | California | 90404 | United States |
| Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Siteman Cancer Center - St. Peters | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | United States |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | 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 |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Southern Medical Day Care Centre | Wollongong | New South Wales | 2500 | Australia |
| Onkologicky ustav sv. Alzbety, s.r.o. | Bratislava | 812 50 | Slovakia |
| Univerzitna nemocnica Bratislava | Bratislava | 82101 | Slovakia |
| Narodny ustav srdcovych a cievnych chorob, a.s. | Bratislava | 833 48 | Slovakia |
| MR Poprad s.r.o. | Komárno | 945 01 | Slovakia |
| KARDIO, s.r.o. | Poprad | 058 01 | Slovakia |
| POKO Poprad, s.r.o., Ambulancia klinickej onkologie | Poprad | 058 01 | Slovakia |
| Nemocnica Poprad a.s. | Poprad | 058 45 | Slovakia |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | 05505 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D010051 | Ovarian Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004935 | Esophageal Diseases |
| D010182 | Pancreatic Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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