Phase 2
N=26
Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer
Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02865811 ↗Enrolled (actual)
26
Serious AEs
11.5%
Results posted
Aug 2021
Primary outcome: Primary: Clinical Benefit Rate [CBR] — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pembrolizumab (Drug); Pegylated Liposomal Doxorubicin (PLD) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate [CBR] |
12 | — |
| SECONDARY Safety of the Combination of Pembrolizumab/PLD |
1 | — |
| SECONDARY Overall Response Rate [ORR] |
5; 1 | — |
| SECONDARY Duration of Response [DOR] |
10.58 | — |
| SECONDARY Progression-Free Survival [PFS] |
8.1; 5.6 | — |
| SECONDARY Overall Survival |
18.3 | — |
Summary
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)
* Pembrolizumab
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written informed consent/assent for the trial.
- Be 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1 criteria.
- Have a histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube or peritoneal cancer. All histologies of epithelial ovarian cancer are eligible except for carcinosarcomas.
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment.
- Patients must have platinum resistant cancer with a platinum free interval of 1.5 X institutional ULN
- Hepatic
- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases
- Albumin >2.5 mg/dL
- Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PT)
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.
- Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Exclusion Criteria
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patients cannot have primary platinum refractory cancer, i.e. documented cancer progression while receiving platinum or within one month of receipt of a platinum based regimen.
- Has received a prior anthracycline chemotherapy either for ovarian cancer treatment or another previous malignancy.
- Left ventricular ejection fraction (LVEF) defined by multigated acquisition (MUGA) or echocardiogram which is below the institutional lower limit of normal prior to starting study treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients and/or liposomal doxorubicin.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Participants with < Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If participant underwent major surgery, they must h
Data sourced from ClinicalTrials.gov (NCT02865811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.