Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03092856|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Cancer Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer||Biological: Anti-OX40 Antibody PF-04518600 Drug: Axitinib Other: Laboratory Biomarker Analysis Other: Placebo||Phase 2|
I. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination.
I. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF‐04518600 [OX40 Ab]) compared to axitinib + placebo.
I. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30, 90, and 180 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||July 19, 2017|
|Estimated Primary Completion Date :||July 19, 2020|
|Estimated Study Completion Date :||July 19, 2021|
Experimental: Arm I (axitinib, anti-OX40 antibody PF-04518600)
Patients receive axitinib PO BID on days 1-14 and anti-OX40 antibody PF-04518600 IV over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Biological: Anti-OX40 Antibody PF-04518600
Other Name: PF-04518600
Other: Laboratory Biomarker Analysis
Active Comparator: Arm II (axitinib, placebo)
Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Progression‐free survival (PFS) [ Time Frame: Time from randomization until the earliest of documented disease progression (confirmed progression of disease) or death, assessed for up to 180 days ]The statistical comparison of PFS in the two treatment arms will be based on the stratified logrank test.
- Incidence of unacceptable toxicity [ Time Frame: Up to the beginning of the third course (29 days) ]Defined as any toxicity or toxicities that necessitate the patient being removed from protocol therapy within the first 2 courses of therapy, or which cause a more than 6‐week interruption of therapy or delay in starting a next course, up to the beginning of the 3rd therapy course.
- ORR defined as either complete response or partial response occurring any time during treatment and assessed by RECIST 1.1 and immune-related RECIST (irRECIST) criteria [ Time Frame: Up to 180 days ]The two arms will also be compared using a one‐sided 0.05‐level Pearson chi‐square test.
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): NCT03092856
|Contact: Cheryl Kefauver, RN||323-865-0459||Cheryl.Kefauver@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Sarmad Sadeghi, MD 323-865-0553 email@example.com|
|Principal Investigator: Sarmad Sadeghi|
|University of California Davis Comprehensive Cancer Center||Not yet recruiting|
|Sacramento, California, United States, 95817|
|Contact: Primo N. Lara 916-734-3089|
|Principal Investigator: Primo N. Lara|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Brian I. Rini 866-223-8100|
|Principal Investigator: Brian I. Rini|
|Ohio State University Comprehensive Cancer Center||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Amir Mortazavi 614-293-6196|
|Principal Investigator: Amir Mortazavi|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Rahul A. Parikh 412-647-8073 firstname.lastname@example.org|
|Principal Investigator: Rahul A. Parikh|
|Principal Investigator:||Sarmad Sadeghi||University of Southern California|