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RecruitingLast updated: 5 February 2024

KEYNOTE-C11: This phase II trial is evaluating how effective a treatment of immunotherapy (pembrolizumab), followed by chemotherapy, and then followed with more immunotherapy is in people with newly diagnosed classical Hodgkin lymphomaPhase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

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 patients with Hodgkin's lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

KEYNOTE-C11

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Merck

Scientific Title

Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

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 have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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