Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02440425|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Pembrolizumab Drug: Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Dose Dense (Weekly) Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Recurrent Ovarian Cancer|
|Actual Study Start Date :||August 12, 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Combination Therapy
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
- Progression-free Survival (PFS) at 6 Months [ Time Frame: 6 months ]6-month progression-free survival of the combination of weekly paclitaxel with pembrolizumab (MK-3475). PFS: The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Progressive Disease (PD): Sum of the longest diameters (SLD) increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify).
- Occurrence of Adverse Events [ Time Frame: 2 years, 6 months ]Safety of the combination of paclitaxel weekly with pembrolizumab every 3 weeks (Q3W). Serious Adverse Events and Adverse Events will be reported in that Results Data section, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
- Response Rate (RR) [ Time Frame: Up to 36 months ]Proportion of participants who respond to the regimen by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, RECIST based immune-related response criteria (irRC), and exploration of Cancer Antigen (CA) 125 Rustin Criteria. RECIST v1.1: Complete Response (CR) - Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis. Partial Response (PR) - At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. RR=CR + PR.
- Disease Control Rate (DCR) [ Time Frame: Up to 36 months ]DCR: The percentage of participants complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. DCR=CR + PR + (SD x 2 mo.)
- Duration of Response (DOR) [ Time Frame: Up to 36 months ]Duration of Response in months. DOR= Duration from first observation of partial response to the time of disease progression.
- Median Overall Survival (OS) [ Time Frame: Up to 36 months ]OS: The time from randomization until death from any cause.
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): NCT02440425
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Virginia|
|VCU Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Robert Wenham, M.D.||H. Lee Moffitt Cancer Center and Research Institute|