Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a non-randomised trial with one experimental arm with several phases. All participants will first receive pembrolizumab administered intravenously (via IV) at a dose of 200mg on Day 1 of each 3-week cycle for 3 cycles. All participants will then undergo Positron Emission Tomography (PET) scans, and depending on these results, will receive one of two chemotherapy regimens. Some participants will receive AVD chemotherapy which involves doxorubicin in combination with vinblastine & dacarbazine, and other participants will receive escBEACOPP chemotherapy which involves etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, & prednisone. Following chemotherapy, all participants will receive more pembrolizumab as consolidation therapy. This time, pembrolizumab will be administered via IV at a dose of 400mg on Day 1 of each 6-week cycle for 4 cycles.
Conditions
This trial is treating people with Hodgkin's lymphoma
Eligibility
Inclusion
The main inclusion criteria include, but are not limited to the following:
- Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
- Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
Exclusion
The main exclusion criteria include, but are not limited to the following:
- Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- Has an uncontrolled intercurrent cardiovascular illness
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- 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
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history or current evidence of pulmonary fibrosis
- Has had an allogenic tissue/solid organ transplant
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck
Scientific Title
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)
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