A Phase II Trial of Pembrolizumab and Lenvatinib in Patients With Recurrent or Persistent Clear Cell Carcinoma of the Ovary
Overview
- Phase
- Phase 2
- Intervention
- Lenvatinib
- Conditions
- Ovarian Clear Cell Carcinoma
- Sponsor
- Elizabeth K. Lee MD
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- 6 Month Progression-free survival (PFS) Rate
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This research study is being done to test the efficacy and safety of combining the study drugs pembrolizumab and lenvatinib in patients with clear cell ovarian cancer.
The names of the study drugs involved in this study are:
- Lenvatinib
- Pembrolizumab
Detailed Description
This is an open label, non-randomized, single cohort phase II trial. Participants with recurrent or persistent clear cell ovarian carcinoma (CCOC) will be treated with the investigational combination of pembrolizumab and lenvatinib until progression of disease or unacceptable toxicity. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment until progression of disease or unacceptable toxicity. Participants will be followed for 36 months thereafter. It is expected that about 31 people will take part in this research study. 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 drugs work in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved lenvatinib or pembrolizumab for your specific disease but it has been approved for other uses.
Investigators
Elizabeth K. Lee MD
Sponsor-Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) (≥50% clear cell histology).
- •Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST v1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.
- •Prior bevacizumab is allowed.
- •Prior use of immune checkpoint inhibitors (e.g. anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for up to 30% of participants.
- •Unlimited prior lines for the treatment of recurrent or persistent disease are allowed.
- •Age ≥18 years. Because no dosing or adverse event data are currently available on the use of the combination of pembrolizumab/lenvatinib in participants \<18 years of age, children are excluded from this study.
- •ECOG performance status of 0 or 1 (Karnofsky performance scale ≥70%).
- •Participants must have adequate organ and marrow function as defined below:
- •absolute neutrophil count ≥1,500/μcL
Exclusion Criteria
- Not provided
Arms & Interventions
PEMBROLIZUMAB and LENVATINIB
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab Treatment will continue until progression of disease or unacceptable toxicity. Participants will be followed for up to 36 months after discontinuation of study treatment.
Intervention: Lenvatinib
PEMBROLIZUMAB and LENVATINIB
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab Treatment will continue until progression of disease or unacceptable toxicity. Participants will be followed for up to 36 months after discontinuation of study treatment.
Intervention: Pembrolizumab
Outcomes
Primary Outcomes
6 Month Progression-free survival (PFS) Rate
Time Frame: Disease will be evaluated at baseline and every 3 cycles on treatment, where each cycle is 3 weeks. Relevant to this endpoint is the 6 month timepoint.
6-month PFS rate is the proportion of participants who are alive and progression-free at 6 months. Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death.
Overall Response Rate (ORR)
Time Frame: ORR expected to be observed up to 3 years
The objective response rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment.
Secondary Outcomes
- Grade 3 or Higher Treatment-Related Toxicity Rate(AEs expected to be observed up to 3 years)
- Clinical Benefit Rate (CBR)(Disease will be evaluated every 3 cycles on treatment (each cycle is 3 weeks); Treatment continues until disease progression or unacceptable toxicity. Treatment duration is expected to be up to 3 years.)
- ORR by PD-L1 expression status(ORR is expected to be observed up to 3 years)
- [immune RECIST] Objective Response Rate (ORR)([immune RECIST] ORR is expected to be observed up to 3 years)
- [immune RECIST] Median Progression-free Survival (PFS)(Disease is evaluated at baseline, every 3 cycles on treatment, and in follow-up every 6 months (off due to PD) or every 3 months (off not due to PD), up to 3 years)
- Median Progression-free survival (PFS)(Disease is evaluated at baseline, every 3 cycles on treatment (each cycle is 3 weeks), and in follow-up every 6 months (off due to PD) or every 3 months (off not due to PD), up to 3 years.)
- Median Overall Survival (OS)(Survival is evaluated in follow-up every 6 months (off due to PD) or every 3 months (off not due to PD), up to 3 years.)
- [immune RECIST] 6 Month Progression-free survival (PFS) Rate(Disease will be evaluated at baseline and every 3 cycles on treatment, where each cycle is 3 weeks. Relevant to this endpoint is the 6 month timepoint.)
- [immune RECIST] Median Overall Survival (OS)(Survival is evaluated in follow-up every 6 months (off due to PD) or every 3 months (off not due to PD), up to 3 years.)
- [immune RECIST] clinical benefit rate (CBR)(Disease will be evaluated every 3 cycles on treatment; Treatment is continued until disease progression or unacceptable toxicity. Treatment duration is expected to be up to 3 years.)