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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody™ Therapeutic CX 072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors (PROCLAIM-CX-072)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03993379

Background Information

The purpose of this study is to explore the possible side effects, safety, tolerability, and effectiveness of CX-072 when given in combination with ipilimumab in participants with solid tumors. This study will also look at the amount of CX-072 and ipilimumab in the blood and how long it remains in the body. The study also will measure whether or not the body develops antibodies to CX-072.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Over the age of 18 years
  • Agree to provide tumor tissue and blood samples for biomarker assessment
  • Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
  • Subjects with treated brain metastases are eligible if the brain metastases are stable (no magnetic resonance imaging [MRI] evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study treatment) and the subject does not require radiation therapy or steroids. Active screening for brain metastases (eg, brain computed tomography [CT] or MRI) is not required
  • Additional eligibility in protocol

Ineligibility Information

  • Prior therapy with a chimeric antigen receptor T cell–containing regimen
  • History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
  • History of myocarditis regardless of the cause
  • Subjects with acute or chronic hepatitis B or C
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03993379