ADVL1412 - Phase I/II Study of Nivolumab as a single agent and combined with Ipilimumab

ADVL1412 - A Phase I/II Study of Nivolumab in children, and adolescents with recurrent or refractory solid tumors as a single agent and in combination with Ipilimumab

Diseases

Patients must have recurrent or refractory solid tumors, without CNS tumors or known CNS metastases. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.

Description

Nivolumab and ipilimumab are immunomodulatory “checkpoint inhibitors” that induce antitumor effects by blocking inhibitory immune receptors, specifically PD-1 (nivolumab) and CTLA4 (ipilimumab). Nivolumab alone is given IV every 2 weeks in the first part of the study. After the optimal dose of single-agent nivolumab is determined, additional patients will receive nivolumab in combination with ipilimumab administered every three weeks x 4 followed by nivolumab alone every 2 weeks until disease progression or toxicity.

Eligibility Criteria

  • Patients must be between 12 months and 18 years of age. A separate cohort of patients may include ages up to 30 years.
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
  • Patients must not have received prior therapy with nivolumab or ipilimumab.
  • Must have adequate organ function as evidenced by laboratory criteria.
  • Patients must not have any evidence of dyspnea at rest, exercise intolerance due to pulmonary insufficiency, or pulse oximetry < 92% while breathing room air.
  • Patients must not be receiving chronic systemic corticosteroids.
  • Must not have a CNS tumor or known CNS metastases.
  • Must not have a history of any autoimmune disorder.
  • Must not have known HIV, hepatitis B or C, or an uncontrolled infection.
  • Must not have received prior allogeneic transplants or prior solid organ transplantation.
  • Must not have received prior anti-PD1 directed therapy (mAb or small molecule).

Contact

For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur,RN, MSN, CPNP, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at kamazur@txch.org.