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A Randomized Phase 3 Trial of Nivolumab in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Clinical Trial Details

Treatment for Primary Mediastinal (Thymic) Large B-Cell Lymphoma (PMBCL) involves chemotherapy combined with an immunotherapy called rituximab. This combination is also known as the chemo-immunotherapy backbone. There are two types of chemo-immunotherapy backbone treatments for PMBCL: either R-CHOP or DA-EPOCH-R.
   
These drugs effectively treat PMBCL, but are known to cause long-term side effects at high doses. Side effects are unintended and unwanted results of treatment. Study doctors are interested in finding an effective treatment that improves the outcome of PMBCL.
   
Nivolumab is a type of cancer treatment which uses the immune system to fight cancer. We will be using nivolumab with chemo-immunotherapy and comparing the results with only chemo-immunotherapy in newly diagnosed PMBCL. By doing this study, we are hoping that we can figure out the best way to treat PMBCL while also improving outcomes.
   
This study looks at how well the addition of nivolumab to chemo-immunotherapy works when given to children, adolescents, and adults with PMBCL. Nivolumab is experimental because it has not been proven to work in people with PMBCL.
   
Other goals of this study include understanding the biology and treatment of PMBCL.

Key Eligibility: 

   - Age 2 years or older

   - Diagnosed primary mediastinal B-cell lymphoma (PMBCL)

   - Limited prior anti-cancer therapy if had a previous malignancy

   - No previous cancer which required systemic chemotherapy or/and thoracic radiation

   - No uncontrolled concurrent diseases/infections/conditions

   - No pregnancy or breastfeeding

   - Usage of adequate contraception if sexually active

Detailed eligibility to be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Lisa Bayer, NP
(212) 746-3413
lbayer@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2106023669

ClinicalTrials.gov:

NCT04759586

Sponsor:

ANHL1931

Status

Open to Enrollment

Age Group

Adult , Pediatric

Sponsor

Disease