PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy

Conditions

• Ann Arbor Stage I Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Ann Arbor Stage II Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Ann Arbor Stage III Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Ann Arbor Stage IV Primary Mediastinal (Thymic) Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brentuximab Vedotin — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin — DRUG
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV
• Prednisone — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Rituximab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies the effect of brentuximab vedotin and nivolumab alone and in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone in treating patients with untreated, stage I-IV primary mediastinal large B-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent, called vedotin. Brentuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD30 receptors, and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a type of antibody therapy, which targets and attaches to the CD20 protein found on the surface of blood cells with cancer and some healthy blood cells. Chemotherapy drugs, such as cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, or by stopping them from dividing. Prednisone is a steroid, a hormone (chemical messengers) with multiple roles, notably in the immune system and inflammation reduction. Steroids are poisonous to lymphocytes (white blood cells from which lymphomas develop). Giving brentuximab vedotin and nivolumab in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone may help to control the disease and be a less harmful regimen than standard chemotherapy in patients with primary mediastinal large B-cell lymphoma.

Key Dates

Start date

May 10, 2021

Status verified

Feb 2026

Primary completion

Aug 3, 2027

Completion

Aug 3, 2027

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (brentuximab vedotin, nivolumab, R-CHP)
  Patient will receive an immune lead-in of 2 cycles of Brentuximab vedotin and Nivolumab (A-O) (cycles 1 and 2), which has an appropriate futility rules in place to close early if efficacy targets are not met. At cycle 3 and 4, patients will receive A-O with R-CHP. Patients who will have achieved complete response (CR) at PET/CT before cycle 5 will receive 2 more cycles of A-O-R-CHP (cycle 5 and 6) and A-O only for cycle 7 and 8. If these patients still present CR at PET/CT after cycle 8, they will have completed therapy and will be followed up. In case of stable disease or progressive disease at PET/CT after cycle 4, the patient will be taken off the trial. Patients who present further response but no CR, at PET/CT before cycle 5 will receive 4 more cycles A-O-R-CHP (cycles 5-8). If they reach CR at PET/CT after cycle 8, they will have completed therapy and will be followed up. All patients will receive a total of 8 cycles of A-O. The cycle duration is 21 days.

Primary Outcome Measure

Complete response rate [ Time Frame: At completion of therapy, assessed up to 2 years ]

Central Contacts

• Ranjit Nair
  (281) 787-7904
  [email protected]
• Ranjit Nair
  (281) 787-7904

Locations (1)

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