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Pituitary Cancer

Gerald Raverot, MD PhD

Emmanuel Jouanneau, MD PhD

The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

DNA and pituitary tumor frozen sample (Neurobiotec Biological Resource Centre (BRC) of Hospices Civils de Lyon (HCL))

PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon

PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)

Clinical, biochemical et imaging evaluation of a cohort of patient operated in the referral center for pituitary tumor.

Identification of recurrence or progression an analysis of the clinicopathological classification.

Evaluation of the different therapeutic strategies (med, surgery, chemotherapies, radiation therapy) to prevent recurrence or tumor progression.

Analysis of the expression of SST receptors in GH, PRL and ACTH secreting pituitary tumors: SSTR expression accessed by immunohistochemistry of the pituitary tumor.

Evaluation of the response to somatostatine analogs: somatostatine analogs efficacy evaluated by normalization of hormone hypersecretion in ACTH, GH and PRL secreting pituitary tumor.

Evaluation of MGMT expression (accessed by immunohistochemistry of the pituitary tumor) and response to temozolomide treatment (evaluated according to RECIST criteria) for patient presenting multirecurrent tumors resistant to conventional treatment.

Hospices Civils de Lyon

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will have a pituitary adenoma/carcinoma of any histology

Nivolumab 1 mg/kg every 3 weeks for 4 cycles

Following concurrent ipilimumab and nivolumab, patients will receive single agent nivolumab at 480 mg every 4 weeks for 6 cycles (1 cycle=4 weeks) with the option of continuing until disease progression or until the end of the study, whichever occurs first

Andrew Lin, MD

The purpose of this study is to determine if nivolumab and ipilimumab are effective treatment for people with pituitary tumors have gotten worse after surgery and radiation.

Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors

Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Aggressive Pituitary Tumors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Radiographic response rate will be assessed by RANO/iRANO

Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 will be used to assess safety

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon	NCT02854228	Pituitary Tumor		-	Hospices Civils de Lyon
Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors	NCT04042753	Pituitary Pituitary Tumor Pituitary Carci... Pituitary Cance...	Ipilimumab Nivolumab Nivolumab	18 Years -	Memorial Sloan Kettering Cancer Center
PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon	NCT02854228	Pituitary Tumor		-	Hospices Civils de Lyon

Spots Global Cancer Trial Database for pituitary carcinoma