Nivolumab for Lymphoma

Palo Alto (17 mi)

Overseen bySteven Park, MD

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Steven Park, MD

No Placebo Group

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls

Eligibility Criteria

This trial is for people aged 65 or older with Primary CNS Lymphoma (PCNSL) who have already had some chemotherapy but not radiation therapy for PCNSL. They should be able to perform daily activities with varying degrees of assistance (ECOG 0-3), have CD20 positive lymphoma, and adequate organ function. Women must not be pregnant, breastfeeding, and willing to use effective contraception.

Inclusion Criteria

I am 65 years old or older.

I have recovered from side effects of my previous treatment, except for hair loss.

My lymphoma is confirmed to be CD20 positive.

My kidney function is within the normal range.

I've completed at least 2 cycles of strong methotrexate chemotherapy without my cancer getting worse.

My cancer was measurable by scans before starting my first treatment.

Exclusion Criteria

I do not have active lung inflammation.

My lymphoma is present in my body but not in my brain.

Treatment Details

The trial tests Nivolumab as a follow-up treatment after initial chemotherapy in older patients with brain lymphoma. It's split into two stages: first to find a safe dose based on side effects, then to see if it helps stop the cancer from getting worse over two years compared to past data.

2Treatment groups

Experimental Treatment

Group I: Stage 2Experimental Treatment1 Intervention

Expansion Cohort

Group II: Stage 1Experimental Treatment1 Intervention

Safety Run-In