Combination of DPX-Survivac and Pembrolizumab for Relapsed Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2b clinical trial evaluates the safety and efficacy of a combination treatment involving DPX-Survivac and pembrolizumab, with and without the addition of low-dose cyclophosphamide, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study will enroll up to 102 participants who will be randomized into two groups: one receiving all three treatments and the other receiving only DPX-Survivac and pembrolizumab. Participants will receive multiple doses of DPX-Survivac and pembrolizumab over a specified treatment schedule, with the option of intermittent cyclophosphamide for one group. The goal is to assess how well this combination therapy works in this patient population.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Adults ≥ 18 years of age who are willing and able to provide written informed consent
* Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.
* Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.
* Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).
* Subjects must have failed or be ineligible for ASCT or CAR-T
* Have at least one bi-dimensionally measurable lesion per Lugano (2014)
* Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
* Meet protocol-specified laboratory requirements
* Life expectancy \> 3 months.

Key Exclusion Criteria:

* Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis
* Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter
* Radiotherapy within 14 days of day 0
* Autologous stem cell transplant (ASCT) within ˂100 days prior to D0
* Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0
* Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years
* Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)
* Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment

Where it's running

• Compassionate Cancer Care Medical Group
  Fountain Valley, California, United States Recruiting
• Blood and Marrow Transplant Group of Georgia
  Atlanta, Georgia, United States Recruiting
• Indiana University Health Melvin and Bren Simon Cancer Center
  Indianapolis, Indiana, United States Recruiting
• Tulane Cancer Center Office of Clinical Research
  New Orleans, Louisiana, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists
  Omaha, Nebraska, United States Recruiting
• Christus St. Vincent Regional Cancer Center
  Santa Fe, New Mexico, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.