Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT02865811|
Recruitment Status : Active, not recruiting
First Posted : August 12, 2016
Last Update Posted : August 21, 2017
This research study is studying the combination of Pegylated Liposomal Doxorubicin (PLD) and Pembrolizumab as a possible treatment for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer that is resistant to platinum therapy.
The following interventions will be used in this study:
- Pegylated liposomal doxorubicin (PLD)
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Pembrolizumab Drug: Pegylated Liposomal Doxorubicin (PLD)||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The investigators are looking to see if combining the standard therapy, PLD, and the study drug, Pembrolizumab, will be better than PLD alone. Pembrolizumab is a drug called a monoclonal antibody. Pembrolizumab blocks and interferes with a protein called PD-1; PD-1 can help the cancer cell evade the immune system, and thereby blocking PD-1 may help the immune system recognize and kill cancer cells.
This will be the first time this combination will be tested for participants with Ovarian, Fallopian Tube or Peritoneal Cancer. Therefore, a group of 6 participants will be treated in a "safety lead in" portion of the trial. This lead in will determine the safest dose of PLD when given in combination with the study drug Pembrolizumab. These 6 participants will be treated with Pembrolizumab and PLD at the FDA approved dose to see if the combination is well tolerated or too severe. If the combination is well tolerated, 20 additional participants will be added. If the side effects are too severe, the dose of PLD will be lowered.
The FDA (the U.S. Food and Drug Administration) has approved PLD as a treatment option for this disease, but has not approved Pembrolizumab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab Combined With Pegylated Liposomal Doxorubicin (PLD) For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer|
|Actual Study Start Date :||September 15, 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2024|
Experimental: Pembrolizumab in Combination With PLD
A safety lead in with 6 patients will be studied prior the start of the treatment.
Please see "Arms" for description.
Other Name: Keytruda
Drug: Pegylated Liposomal Doxorubicin (PLD)
Please see "Arms" for description.
- Clinical Benefit Rate [ Time Frame: 24 Weeks ]
- Progression Free Survival [ Time Frame: 24 weeks ]
- Objective Response measured by RECIST 1.1 [ Time Frame: 24 weeks ]Measured by RECIST 1.1
- Toxicity measured by CTCAE [ Time Frame: 24 weeks ]Measured by CTCAE
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865811
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Northwell Hospital Monter Cancer Center|
|Lake Success, New York, United States, 11042|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|