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Pembrolizumab · 1 trial · 3 indications
To determine the ctDNA/MRD negative, PET negative complete response rate for cHL, participants undergoing treatment with pembro + GVD will have a composite response incorporating the following two criteria: (1) Absence of detectable cHL ctDNA as assessed by Foresight CLARITY LDT after 2 cycles of treatment and (2) complete response by Fluorodeoxyglucose (FDG) PET/CT, assessed by Lugano criteria after 2 cycles, or 4 if participant demonstrates indeterminate response (IR) after 2 cycles. Lugano classification for response using FDG PET-CT is as follows: A score is given which ranges from 1 (No uptake above background) to 5 (Hottest area of uptake markedly \> liver and/or new lesions present). A CR is defined as a score of 1,2,3 in nodal or extranodal sites with or without a residual mass. Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) will be used to distinguish IR, SD or PD. Response rate will be summarized by percentage, along with 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (Pembrolizumab + GVD) | EXPERIMENTAL | All participants receive 2, 21-day cycles of 200 mg Pembrolizumab (pembro) on day 1 of each cycle (pembro) and 1000mg Gemcitabine, 20mg/m\^2 of Vinorelbine, Liposomal doxorubicin 15 mg/m2 (GVD) on days 1 and 8 of each cycle for up to 2 cycles. Pegfilgrastim is administered on day 8 or 9 of each cycle. FDG-PET/CT imaging and Foresight CLARITY LDT ctDNA response after 2 cycles will determine if participants are eligible for an additional 2 cycles of pembro + GVD or salvage therapy and ASCT. Participants may be able to qualify for consolidation without ASCT (pembro and/or 30 Gy ISRT) depending on response. Radiographic response after 4 cycles will be conducted to determine eligibility for consolidation without ASCT for participants with CR or standard of care salvage therapy and ASCT, for participants with partial response (PR), stable disease (SD), or progressive disease (PD) after a second administration of pembro+GVD. Participants are followed for up to 5 years. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Given intravenously |
| Non-investigational, involved site radiotherapy (ISRT) | RADIATION | Undergo possible, standard of care, non-investigational radiation therapy |
| Gemcitabine | DRUG | Given IV |
| Vinorelbine | DRUG | Given IV |
| Liposomal Doxorubicin | DRUG | Given IV |
| Foresight CLARITY™ LDT | DEVICE | Foresight CLARITY LDT, a laboratory-developed test (LDT),by Foresight Diagnostics, is an ultra-sensitive liquid biopsy and tissue platform that detects MRD in patients with B-cell lymphomas |
| Pegfilgrastim | DRUG | Given IV for supportive care |
| Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Undergo imaging |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma). 3. Participants must have relapsed or refractory disease after no more than one line of systemic t...
Pembrolizumab is being studied for the treatment of adult patients with relapsed or refractory Hodgkin Lymphoma, including classic Hodgkin Lymphoma. It is currently in Phase 2 clinical development for this indication, with an ongoing trial evaluating ctDNA-guided therapy in this patient population.
Pembrolizumab is a monoclonal antibody (a -mab class drug) that targets the PD-1 receptor. By binding to PD-1, it is designed to block the interaction with its ligands, which can help the immune system recognize and attack cancer cells.
Pembrolizumab is being developed by Natera, Inc. (NASDAQ: NTRA). The company is conducting a Phase 2 clinical trial of the drug in patients with relapsed or refractory Hodgkin Lymphoma.
Pembrolizumab is in Phase 2 clinical development for Hodgkin Lymphoma. It is an investigational drug for this indication and has not been approved by the FDA for this use. The ongoing Phase 2 trial is currently recruiting participants in the United States.
Pembrolizumab is being evaluated in the clinical trial NCT07021989, titled "ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma." This Phase 2, uncontrolled, open-label trial is recruiting 38 adult patients in the United States and is not randomized or double-blinded.
Pembrolizumab is the generic name for the drug also known as Keytruda. In the context of this development program, it is being studied by Natera, Inc. for Hodgkin Lymphoma, and the ongoing trial NCT07021989 is evaluating its use in this patient population.