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Squamous Cell Carcinoma of the Head and NeckPhase 1NCT04152018

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

A Phase 1 study testing PF-06940434 and PF-06801591 in people with Squamous Cell Carcinoma of the Head and Neck and Renal Cell Carcinoma, run by Pfizer at 31 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-06940434 and PF-06801591
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
31 sitesin 5 countries
Study dates
13 Nov 2019to 10 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

United States18 sites

  • Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Duke Univ. Medical Center/Duke Cancer Center

    Durham, North Carolina, 27710

  • Investigational Chemotherapy Service

    Durham, North Carolina, 27710

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

  • NEXT Oncology

    San Antonio, Texas, 78229

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • HonorHealth Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85260

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

Other trials in United States

Slovakia7 sites

  • Onkologicky ustav sv. Alzbety, s.r.o.

    Bratislava, 812 50

  • Univerzitna nemocnica Bratislava

    Bratislava, 82101

  • Narodny ustav srdcovych a cievnych chorob, a.s.

    Bratislava, 833 48

  • MR Poprad s.r.o.

    Komárno, 945 01

  • KARDIO, s.r.o.

    Poprad, 058 01

  • POKO Poprad, s.r.o., Ambulancia klinickej onkologie

    Poprad, 058 01

  • Nemocnica Poprad a.s.

    Poprad, 058 45

Other trials in Slovakia

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

South Korea2 sites

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

Australia1 site

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS

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.

Being tested
PF-06940434, PF-06801591
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Ovarian Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Bile Duct Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06940434Drug

    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

  • PF-06801591Drug

    Also called Anti-PD-1

    PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Study groups in NCT04152018
Study groupRoleWhat they receive
Dose EscalationExperimentalSingle Agent Dose Escalation
Receives: Drug: PF-06940434
Dose Finding Anti-PD-1 Combination 1ExperimentalPart 1B PF-06940434 plus anti-PD-1
Receives: Drug: PF-06940434; Drug: PF-06801591
Dose Expansion Arm AExperimentalPF-06940434 with anti-PD-1 in SCCHN
Receives: Drug: PF-06940434; Drug: PF-06801591
Dose Expansion Arm BExperimentalPF-06940434 with anti-PD-1 in RCC
Receives: Drug: PF-06940434; Drug: PF-06801591
Dose Expansion, Arm CExperimentalPF-06940434 with anti-PD-1 (both Q3W)
Receives: Drug: PF-06940434; Drug: PF-06801591

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding

    Measured: Baseline up to 28 Days (Cycle 1)

  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Measured: Baseline up to approximately 24 months

  3. Number of Participants With Adverse Events (AEs) According to Severity

    Measured: Baseline up to approximately 24 months

  4. Number of Participants With Adverse Events (AEs) According to Seriousness

    Measured: Baseline up to up to approximately 24 months

  5. Number of Participants With Adverse Events (AEs) by Relationship

    Measured: Baseline up to approximately 24 months

  6. Progression-Free Survival (PFS) for Dose Expansion

    The period from study entry until disease progression, death or date of last contact.

    Measured: Baseline up to 24 Months

  7. Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion

    Measured: Baseline up to 24 months

  8. Duration of Response (DR) for Dose Expansion

    Measured: Baseline up to 24 Months

Secondary outcomes (20)

  1. PF-06940434 after multiple doses PK parameters (Cmax).

    Maximum observed plasma concentration of PF-06940434.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. Systemic Clearance (CL)

    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

    Measured: 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).

  4. Volume of Distribution (Vd)

    Measured: 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).

  5. Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.

    Measured: 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).

  6. Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.

    Titers of neutralizing antibodies (NAb) against PF-06940434.

    Measured: 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).

  7. PK parameters of PF-06940434 and PF-06801591 (Cmax).

    Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).

    Measured: 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)

  8. 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.

    Measured: 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)

  9. Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.

    Maximum observed plasma concentration of PF-06940434.

    Measured: Cycle 4 Day 1 (each cycle is 28 days)

  10. 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.

    Measured: Cycle 4 Day 1 (each cycle is 28 days)

  11. Number of participants with increased T-cells after PF-06940434 treatment.

    Measured: Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)

  12. Progression-Free Survival (PFS) for Dose Expansion

    The period from study entry until disease progression, death or date of last contact.

    Measured: Baseline to measured progression (up to approximately 24 months)

  13. Duration of Response (DR)

    Measured: Baseline up to approximately 24 Months

  14. Number of Participants With Objective Response for Dose Expansion portion

    Measured: Baseline up to 24 months

  15. 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.

    Measured: Every 8 weeks from the time of enrollment up to 2 years

  16. Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion

    Measured: 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)

  17. Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: 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]

  18. 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.

    Measured: 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].

  19. 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.

    Measured: 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].

  20. Overall Survival

    The period from study entry until death or date of last contact (24 months)

    Measured: From baseline to up to 2 years after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start13 Nov 2019
  3. Primary completion10 Dec 2024
  4. Study completion10 Dec 2024

Why it stopped: Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152018
Sponsor's protocol ID
C3891001
Other IDs
2020-004009-29
Status last verified
May 2025
First submitted
30 Oct 2019
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06940434 and PF-06801591 in people with Squamous Cell Carcinoma of the Head and Neck and Renal Cell Carcinoma, run by Pfizer at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Slovakia, Taiwan, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding (time frame: Baseline up to 28 Days (Cycle 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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