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

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NCT04152018

Last updated on November 14, 2019
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Study Location
NEXT Oncology
San Antonio, Texas, 78229 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- Adequate bone marrow, kidney and liver function.

- Performance status of 0 or 1.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Participant disease status is suitable for local therapy administered with curative
intent.

- Hypertension that cannot be controlled by medications.

NCT04152018
Pfizer
Not yet recruiting
Study of PF‑06940434 in Patients With Advanced or Metastatic Solid Tumors.

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Descriptive Information
Brief Title  ICMJE Study of PF?06940434 in Patients With Advanced or Metastatic Solid Tumors.
Official Title  ICMJE 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
Brief SummaryOpen-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 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), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: PF-06940434
    PF-06940434 is given intravenously (IV) every 2 weeks in a 28 day cycle. Multiple dose levels will be evaluated
  • Drug: PF-06801591
    PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle.
    Other Name: Anti-PD-1
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Single Agent Dose Escalation
    Intervention: Drug: PF-06940434
  • Experimental: Dose Finding Anti-PD-1 Combination 1
    Part 1B PF-06940434 plus anti-PD-1
    Interventions:
    • Drug: PF-06940434
    • Drug: PF-06801591
  • Experimental: Dose Finding Anti-PD-1 Combination 2
    Part 1C PF-06940434 plus anti-PD-1
    Interventions:
    • Drug: PF-06940434
    • Drug: PF-06801591
  • Experimental: Dose Expansion Arm A
    PF-06940434 with anti-PD-1 in SCCHN
    Interventions:
    • Drug: PF-06940434
    • Drug: PF-06801591
  • Experimental: Dose Expansion Arm B
    PF-06940434 with anti-PD-1 in RCC
    Interventions:
    • Drug: PF-06940434
    • Drug: PF-06801591
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2019)		104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 27, 2023
Estimated Primary Completion DateJune 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04152018
Other Study ID Numbers  ICMJE C3891001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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