Nivolumab for Advanced Cancers with Autoimmune Disorders

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

Recruiting Phase 1 Interventional Study
Autoimmune Disease Crohn Disease Dermatomyositis Hematopoietic and Lymphoid Cell Neoplasm Inflammatory Bowel Disease Malignant Solid Neoplasm Multiple Sclerosis Psoriasis Psoriatic Arthritis Rheumatoid Arthritis Sjogren Syndrome Systemic Lupus Erythematosus Systemic Scleroderma Ulcerative Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for adults with advanced cancers who also have autoimmune disorders. Participants will receive treatments that may include the drug nivolumab and possibly others to see how well they work together.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have an advanced cancer that is either spread or cannot be removed by surgery.
  • I have a histologically confirmed type of cancer that is approved for nivolumab treatment.
  • I have been diagnosed with an autoimmune disorder.
  • I have a life expectancy of more than 12 weeks.
  • I can understand and sign a consent form.

You may not be able to join if

  • I have had severe side effects from previous immunotherapies.
  • I have active brain metastases that need immediate treatment.
  • I am pregnant or breastfeeding.
  • I have untreated hepatitis B or C infections.
  • I have experienced significant liver issues beyond allowed limits.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (ad…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in…
Contacts

No contact information available.