Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02315066|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: PF-04518600 Drug: PF-04518600 plus PF-05082566||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 23, 2015|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined
Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously
Experimental: PF-04518600 plus PF-05082566
OX40 (CD134) agonist plus 4-1BB (CD137) agonist
Drug: PF-04518600 plus PF-05082566
Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.
Drug: PF-04518600 plus PF-05082566
Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.
- Number of participants with Dose-limiting toxicities (DLT) [Dose Escalation] [ Time Frame: Day 1 up to Day 28 ]First and second cycle DLTs in order to determine maximum tolerated dose
- Overall safety profile [Dose Expansion] [ Time Frame: Day 1 up to Day 28 ]Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities.
- Incidence of anti-drug antibodies and neutralization assays [ Time Frame: 0 hr on Day 1 Cycles 1 to 4, 7 and every other cycle ]Number of participants with the presence of anti-PF-04518600 antibodies and neutralization assays
- Number of participants with objective response [ Time Frame: Baseline, every 6 weeks (Part 1) or 8 weeks (Part 2) until disease progression or unacceptable toxicity ]Number of participants with objective response based on assessment of progression free survival (PFS), time to progression (TTP), duration of stable disease (SD), duration of response (DR) according to RECIST version 1.1 and irRECIST and overall survival (OS).
- Unbound (free) cell surface OX40 in peripheral blood [ Time Frame: 0 hr and scheduled timepoints post dose on Cycles 1 to 3, then 0hr on cycles 4 and 7 ]Levels of free OX40 receptor expressed on T cells in peripheral blood after dosing with PF 04518600 alone or in combination with PF 05082566.
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 hr and scheduled timepoints post dose on Cycles 1 to 6, then 0hr on every cycle ]Cmax will be calculated for PF-04518600 and PF-05082566
- Area under the concentration versus time curve (AUCt) [ Time Frame: 0 hr and scheduled timepoints post dose on Cycles 1 to 6, then 0hr on every cycle ]Area under the plasma concentration versus time curve will be calculated for PF-04518600 and PF-05082566
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315066
|Study Director:||Pfizer CT.gov Call Center||Pfizer|