Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
NCT02315066
ABOUT THIS STUDY
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- Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
- Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.
- Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
- Part B2
Arm 1 only:
1. Ocular melanoma patients with advanced/metastatic disease, or
2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. [Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.] Any questions on prior treatment may be discussed with the Sponsor.
Arm 2 only:
- Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. [Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.]
- Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
- Brain metastases requiring steroids
- Major surgery, Radiation therapy within 4 weeks of starting study treatment (except:
palliative radiotherapy to a limited field is allowed after consultation with
sponsor's medical monitor at any time during study participation, including during
screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6
weeks for mitomycin C or nitrosoureas)
- Active and clinically significant bacterial, fungal, or viral infection
- History of active autoimmune disorders
- History of immune-mediated adverse events requiring immunosuppressive therapy or were
grade 3 or higher related to prior immune-modulatory therapy
- Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)
- Prior anthracycline treatment and at risk of cardiac failure (New York Heart
Association Class 2)
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Descriptive Information | |||||
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Brief Title ICMJE | Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566 | ||||
Official Title ICMJE | A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS | ||||
Brief Summary | To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Masking Description: Open-label Primary Purpose: Treatment
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Condition ICMJE | Neoplasms | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Completed | ||||
Actual Enrollment ICMJE | 176 | ||||
Original Estimated Enrollment ICMJE | 180 | ||||
Actual Study Completion Date ICMJE | November 25, 2020 | ||||
Actual Primary Completion Date | November 25, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Arm 1 only:
Arm 2 only:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, Japan, Netherlands, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02315066 | ||||
Other Study ID Numbers ICMJE | B0601002 2014-004107-75 ( EudraCT Number ) B0601002 ( Other Identifier: Alias Study Number ) OX40 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |