A Phase I/II Study of the Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma
Overview
- Phase
- Phase 1
- Intervention
- Pembrolizumab
- Conditions
- Relapsed Hodgkin Lymphoma
- Sponsor
- NYU Langone Health
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Assess Safety and Tolerability of the Combination of Pembrolizumab and Lenalidomide (Number of Drug Related Adverse Events)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
This trial is to assess the safety & efficacy of the Combination of Pembrolizumab and Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.
Detailed Description
There is an emerging clinical data to confirm that Programmed death-1 (PD-1)blockade is safe and viable in lymphoma. The investigators hypothesize that the novel immune platform of pembrolizumab and lenalidomide, will be safe and well tolerated in patients with Relapsed Refractory (RR) Hodgkin Lymphoma (HL) and non-Hodgkin lymphoma (NHL) and that this combination will result in a complete response (CR) rate of 50% in patients with RR HL.
Investigators
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 or evaluable disease, as defined in 2007 Revised Response Criteria for Malignant Lymphoma24 and have received at least two prior therapies. HL patients must not be currently eligible for autologous stem cell transplant.
- •Be willing to provide either archived tumor tissue or tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
- •Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of treatment initiation.
- •Adequate Organ Function Laboratory Values:
- •Absolute neutrophil count (ANC): ≥1,000 /microliter (mcL)
- •Platelets: ≥75,000 / mcL
- •Hemoglobin: ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
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.
- •Has a known history of active Bacillus Tuberculosis (TB)
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •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: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Arms & Interventions
Pembrolizumab and Lenalidomide
An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days
Intervention: Pembrolizumab
Pembrolizumab and Lenalidomide
An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days
Intervention: Lenalidomide
Outcomes
Primary Outcomes
Assess Safety and Tolerability of the Combination of Pembrolizumab and Lenalidomide (Number of Drug Related Adverse Events)
Time Frame: up to 2 years
Assessing the number of drug related adverse events at each dose level of lenalidomide
Estimate Complete Response Rate (CR)
Time Frame: up to 2 years
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Estimate Partial Response Rate (PR)
Time Frame: up to 2 years
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Estimate Overall Response Rate (ORR)
Time Frame: up to 2 years
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Secondary Outcomes
- Estimate the ORR (CR, PR) for Combination Within & Across Dose Levels of Lenalidomide(up to 2 years)
- Estimate Duration of Response (DOR) for the Combination(up to 2 years)
- Estimate Progression Free Survival (PFS) for Combination Within & Across Dose Levels of Lenalidomide(up to 2 years)
- Estimate Stable Disease (SD) for Combination Within & Across Dose Levels of Lenalidomide(up to 2 years)
- Estimate Clinical Benefit (Including SD) for the Combination(up to 2 years)
- Estimate Progression Free Survival (PFS) for the Combination(up to 2 years)