Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

NCT02875067 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 15-00285
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Relapsed Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• Assess Safety and Tolerability of the Combination of Pembrolizumab and Lenalidomide (Number of Drug Related Adverse Events)

  Assessing the number of drug related adverse events at each dose level of lenalidomide

  up to 2 years

• Estimate Overall Response Rate (ORR)

  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

  up to 2 years

• Estimate Complete Response Rate (CR)

  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

  up to 2 years

• Estimate Partial Response Rate (PR)

  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

  up to 2 years

Secondary Outcomes (6)

• Estimate the ORR (CR, PR) 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 Progression Free Survival (PFS) 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

Study Arms (1)

Pembrolizumab and Lenalidomide

EXPERIMENTAL

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

Biological: Pembrolizumab; Drug: Lenalidomide

Interventions

Pembrolizumab BIOLOGICAL

Also known as: MK3475, Keytruda

Pembrolizumab and Lenalidomide

Lenalidomide DRUG

Also known as: Revlimid

Pembrolizumab and Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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)
• Serum creatinine OR: ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN
• Serum total bilirubin: ≤ 1.5 X ULN OR
• Direct bilirubin ≤ ULN for subjects with total bilirubin levels: \>1.5 ULN
• Aspartate aminotransferase (AST) / serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
• Albumin: \>2.5 mg/dL

You may not qualify if:

• 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.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has known history of, or any evidence of active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Sponsors & Collaborators

• NYU Langone Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

NYU Perlmutter Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

pembrolizumab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Catherine Diefenbach, MD
• Organization: NYU Langone Health

Catherine.Diefenbach@nyulangone.org

212-731-5670

Study Officials

• Catherine Diefenbach, MD

  NYU Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 23, 2016
• Study Start: August 29, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-08

Locations

US (3)