EUCTR2021-001244-95-PL
Active, not recruiting
Phase 1
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) - Pembrolizumab and chemotherapy for newly diagnosed classical Hodgkin Lymphoma
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.0 sites140 target enrollmentOctober 5, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Classical Hodgkin Lymphoma
- Sponsor
- Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV cHL. Stage I and II patients may be enrolled, but must have at least one NCCN unfavorable risk factor
- •2\. Has measurable FDG\-avid disease based on investigator assessment according to Lugano 2014 response criteria
- •3\. Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy (including investigational agents) for the treatment of cHL before the first dose of study intervention
- •4\. Is male or female, at least 18 years of age, at the time of signing the informed consent
- •5\. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
- •Pembrolizumab: no contraception requirement
- •Chemotherapy: 90 days
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long\-term and persistent basis) and agree to remain abstinent
Exclusion Criteria
- •1\. Has confirmed nodular lymphocyte\-predominant HL
- •2\. Has an uncontrolled intercurrent cardiovascular illness including, but not limited to the following:
- •Symptomatic congestive heart failure (ejection fraction lower than institutional LLN)
- •Unstable angina pectoris
- •Cardiac arrythmia
- •3\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti PD\-L2 agent or with an agent directed to another stimulatory or coinhibitory T\-cell receptor (eg, CTLA\-4, OX\-40, CD137\)
- •4\. Has received or is expected to receive a live or live\-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •5\. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- •6\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. The
- •use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor
Outcomes
Primary Outcomes
Not specified
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