Last updated on November 2018

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors


Brief description of study

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

This trial enrolls participants for the following cohorts based on condition:

  1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN])
  2. Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx.
  3. Epithelial tumors of major salivary glands
  4. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location
  5. Undifferentiated carcinoma of gastrointestinal (GI) tract
  6. Adenocarcinoma with variants of small intestine
  7. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas)
  8. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary
  9. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma
  10. Intrahepatic Cholangiocarcinoma
  11. Extrahepatic cholangiocarcinoma and bile duct tumors
  12. Sarcomatoid carcinoma of lung
  13. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma.
  14. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma
  15. Trophoblastic tumor: A) Choriocarcinoma
  16. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder
  17. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation
  18. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis
  19. Squamous cell carcinoma variants of the genitourinary (GU) system
  20. Spindle cell carcinoma of kidney, pelvis, ureter
  21. Adenocarcinoma with variants of GU system (excluding prostate cancer)
  22. Odontogenic malignant tumors
  23. Endocrine carcinoma of pancreas and digestive tract
  24. Neuroendocrine carcinoma including carcinoid of the lung
  25. Pheochromocytoma, malignant
  26. Paraganglioma
  27. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex
  28. Desmoid tumors
  29. Peripheral nerve sheath tumors and NF1-related tumors
  30. Malignant giant cell tumors
  31. Chordoma
  32. Adrenal cortical tumors
  33. Tumor of unknown primary (Cancer of Unknown Primary; CuP)
  34. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org]
  35. Adenoid cystic carcinoma
  36. Vulvar cancer
  37. MetaPLASTIC carcinoma (of the breast)
  38. Gastrointestinal stromal tumor (GIST)

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.

TERTIARY OBJECTIVES:

I. To evaluate the association of tumor mutational burden measured by tissue sequencing with durable response (complete response [CR] or partial response [PR] lasting 24 weeks or more).

II. To describe the mutational load and targeted sequencing of well-known oncogenes and changes in these markers of patients at up to three time points (baseline, cycle 2, and progression), and across strata to describe associations with survival outcomes.

III. To describe the presence of germline mutations, and across strata to evaluate association with outcome.

IV. Within strata, to describe patient risk category as defined by the biodesix protein signature and change over time at up to three time points (baseline, cycle 2, progression), and across strata to evaluate associations with outcomes.

V. Within strata, to evaluate the association of PD-L1 expression (positive versus negative) with response and survival outcomes, and within strata, to characterize baseline PD-L1 prevalence.

VI. To collect specimens for banking for use in future correlative biomarker research studies.

OUTLINE

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 10 years from registration.

Clinical Study Identifier: NCT02834013

Contact Investigators or Research Sites near you

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UPMC Washington Hospital Radiation Oncology
Washington, PA United States
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