Study of PF-07265807 in Participants With Metastatic Solid Tumors.

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Metastasis
• Intervention / Treatment: Drug: Axitinib; Drug: PF-07265807; Drug: Sasanlimab

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • HPS Pharmacies Darlinghurst
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Hamilton Health Sciences-Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network
  • Quebec
    • Quebec City, Quebec, Canada, G1J 1Z4
      • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
    • Québec, Quebec, Canada, G1R 2J6
      • CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Province Tumor Hospital
• Italy
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • AN
    • Ancona, AN, Italy, 60126
      • Azienda Ospedaliero Universitaria delle Marche
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori
  • Rome
    • Roma, Rome, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 464-0092
      • Chayagasaka Eye Clinic
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Nagoya, Aichi
    • Nagoya, Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
      • Seoul National University Hospital
    • Songpa-gu, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505
      • Asan Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Fayetteville, Arkansas, United States, 72703
      • Henry Eye Clinic
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Orange, California, United States, 92868
      • UC Irvine Health
    • Orange, California, United States, 92868
      • UCI Chao Family Comprehensive Cancer Center
    • Orange, California, United States, 92868-3201
      • UC Irvine Medical Center
    • Orange, California, United States, 92868-3201
      • UC Irvine Health
    • Orange, California, United States, 92868
      • UCI Medical Center- Outpatient Pharmacy
    • Orange, California, United States, 92868
      • UCI/Chao Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF Investigational Drugs Pharmacy
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94158
      • Clinical & Translational Science Institute
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Lions Eye Institute (RMLEI)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network Cancer Center North
    • Indianapolis, Indiana, United States, 46219
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46227
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network Investigational Drug Services
    • Indianapolis, Indiana, United States, 46256
      • Community Health Network, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Newton, Massachusetts, United States, 02459
      • Dana-Farber Cancer Institute - Chestnut Hill
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas M. D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
• ECOG Performance Status 0 or 1, 2 with approval
• Adequate Bone Marrow Function
• Adequate Renal Function
• Adequate Liver Function
• Resolved acute effects of any prior therapy
• Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
• Life expectancy of at least 3 months.
• Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
• Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
• Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
• Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
• Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
• Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.

Exclusion Criteria:

• Known active uncontrolled or symptomatic CNS metastases.
• Any other active malignancy within 2 years prior to enrollment.
• Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
• Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy.
• Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
• Retinal or other serious ophthalmic disorders as defined in protocol.
• Clinically significant cardiac disease as defined in protocol.
• Uncontrolled HTN that cannot be controlled by medications.
• Inability to consume or absorb study drug.
• Known or suspected hypersensitivity to PF-07265807.
• Prohibited concomitant medications as defined in protocol.
• Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
• Active bleeding disorder.
• Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
• Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.
• Prior treatment with selective AXL/MERTK inhibitors

For participants receiving sasanlimab:

- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy Dose Escalation: Part 1; Monotherapy dose escalation of PF-07265807 in participants with select tumor types.	Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067
Experimental: Doublet Dose Escalation: Part 2; Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.	Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067; Drug: Sasanlimab; Given SC Q3W; Other Names: PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 1; PF-07265807 monotherapy in participants with METex14 mutant NSCLC.	Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067
Experimental: Expansion Phase: Part 4, Cohort 2; PF-07265807 with sasanlimab in participants with MSS CRC	Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067; Drug: Sasanlimab; Given SC Q3W; Other Names: PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 3; PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ	Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067; Drug: Sasanlimab; Given SC Q3W; Other Names: PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 4; PF-07265807 with sasanlimab plus axitinib in participants with RCC	Drug: Axitinib; Dosed per package label starting with 5 mg PO BID; Other Names: AG-013736; Inlyta; Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067; Drug: Sasanlimab; Given SC Q3W; Other Names: PF-06801591; RN-888
Experimental: Triplet Dose Escalation: Part 3; Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.	Drug: Axitinib; Dosed per package label starting with 5 mg PO BID; Other Names: AG-013736; Inlyta; Drug: PF-07265807; Given 2 weeks on/1 week off; Other Names: ARRY-067; Drug: Sasanlimab; Given SC Q3W; Other Names: PF-06801591; RN-888

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)	DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)	Baseline through day 21 or 42
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)	AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy	Baseline through approximately 2 years
Parts 1, 2, and 3: Number of participants with laboratory abnormalities	Laboratory abnormalities as characterized by type, frequency, severity, and timing.	Baseline through approximately 2 years
Part 4: Overall Response Rate (ORR)	Response will be evaluable via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years
Part 4, Cohort 4: Complete Response (CR)	Response will be evaluated via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite	Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab	Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab	Through study completion, an average of 1 year
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib	Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib	Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite	Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab	Single dose (Tmax) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib	Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib	Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite	Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab	Single dose (AUClast) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite	Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib	Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib	Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite	As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab	As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite	As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab	As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807	As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab	As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807	As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807	Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab	As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab	Through study completion, an average of 1 year
Parts 1, 2, and 3: ORR	Response will be evaluable via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years
Part 4: Number of participants with treatment emergent AEs	AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy	Baseline through approximately 2 years
Part 4: Number of participants with laboratory abnormalities	Laboratory abnormalities as characterized by type, frequency, severity, and timing	Baseline through approximately 2 years
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite	Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite	Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite	Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab	Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab	Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib	Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib	Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination	Incidence and titer of anti-sasanlimab ADA response	Through study completion, an average of 1 year
Duration of Response	Response will be evaluable via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years
Disease Control Rate	Response will be evaluable via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years
Progression Free Survival	Response will be evaluable via radiographical tumor assessment by RECIST v1.1	Baseline through approximately 2 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gastric Cancer; Melanoma; Cervical Cancer; Endometrial Cancer; Advanced Cancer; Metastatic Cancer; Esophageal Cancer; Non-small cell lung cancer (NSCLC); Metastatic Solid Tumor; Urothelial carcinoma; Small cell lung cancer (SCLC); Renal cell carcinoma (RCC); Colorectal cancer (CRC); PD-L1 (programmed cell death ligand 1); Merkel Cell Carcinoma; Hepatocellular carcinoma (HCC); TAMK (TAM kinase); MER (mer proto-oncogene); MERTK (mer proto-oncogene tyrosine kinase); AXL (AXL receptor tyrosine kinase); AXL/MER; Selective kinase inhibitor; PD-1 (programmed cell death protein 1); Immune modulator; Solid Tumor Cancer; High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: C4201002; ARRAY-067-102 (Other Identifier: Alias Study Number); 2021-004270-59 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No