Possibia

2834013

Last Update Posted: 2025-04-09

Recruiting has ended

All Genders

accepted

18 Years +

818 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and 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]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018)
  2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
  3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual)
  4. Undifferentiated carcinoma of gastrointestinal (GI) tract
  5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
  6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018)
  7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018)
  8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual)
  9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
  10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
  11. Sarcomatoid carcinoma of lung
  12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma
  13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018)
  14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
  15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual)
  16. 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 (closed to accrual)
  17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual)
  18. Squamous cell carcinoma variants of the genitourinary (GU) system
  19. Spindle cell carcinoma of kidney, pelvis, ureter
  20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018)
  21. Odontogenic malignant tumors
  22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual)
  23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
  24. Pheochromocytoma, malignant (closed to accrual)
  25. Paraganglioma (closed to accrual 11/29/2018)
  26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual)
  27. Desmoid tumors
  28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
  29. Malignant giant cell tumors
  30. Chordoma (closed to accrual 11/29/2018)
  31. Adrenal cortical tumors (closed to accrual 06/27/2018)
  32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
  33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019)
  34. Adenoid cystic carcinoma (closed to accrual 02/06/2018)
  35. Vulvar cancer (closed to accrual)
  36. MetaPLASTIC carcinoma (of the breast) (closed to accrual)
  37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
  38. Perivascular epithelioid cell tumor (PEComa)
  39. Apocrine tumors/extramammary Paget's disease (closed to accrual)
  40. Peritoneal mesothelioma
  41. Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
  42. Clear cell cervical cancer
  43. Esthenioneuroblastoma (closed to accrual)
  44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
  45. Clear cell endometrial cancer
  46. Clear cell ovarian cancer (closed to accrual)
  47. Gestational trophoblastic disease (GTD)
  48. Gallbladder cancer
  49. Small cell carcinoma of the ovary, hypercalcemic type
  50. PD-L1 amplified tumors
  51. Angiosarcoma
  52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible (closed to accrual)
  53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and 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]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018)
  2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
  3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual)
  4. Undifferentiated carcinoma of gastrointestinal (GI) tract
  5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
  6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018)
  7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018)
  8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual)
  9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
  10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
  11. Sarcomatoid carcinoma of lung
  12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma
  13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018)
  14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
  15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual)
  16. 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 (closed to accrual)
  17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual)
  18. Squamous cell carcinoma variants of the genitourinary (GU) system
  19. Spindle cell carcinoma of kidney, pelvis, ureter
  20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018)
  21. Odontogenic malignant tumors
  22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual)
  23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
  24. Pheochromocytoma, malignant (closed to accrual)
  25. Paraganglioma (closed to accrual 11/29/2018)
  26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual)
  27. Desmoid tumors
  28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
  29. Malignant giant cell tumors
  30. Chordoma (closed to accrual 11/29/2018)
  31. Adrenal cortical tumors (closed to accrual 06/27/2018)
  32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
  33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019)
  34. Adenoid cystic carcinoma (closed to accrual 02/06/2018)
  35. Vulvar cancer (closed to accrual)
  36. MetaPLASTIC carcinoma (of the breast) (closed to accrual)
  37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
  38. Perivascular epithelioid cell tumor (PEComa)
  39. Apocrine tumors/extramammary Paget's disease (closed to accrual)
  40. Peritoneal mesothelioma
  41. Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
  42. Clear cell cervical cancer
  43. Esthenioneuroblastoma (closed to accrual)
  44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
  45. Clear cell endometrial cancer
  46. Clear cell ovarian cancer (closed to accrual)
  47. Gestational trophoblastic disease (GTD)
  48. Gallbladder cancer
  49. Small cell carcinoma of the ovary, hypercalcemic type
  50. PD-L1 amplified tumors
  51. Angiosarcoma
  52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible (closed to accrual)
  53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

Eligibility

Relevant conditions:

Acinar Cell Carcinoma

Adenoid Cystic Carcinoma

Adrenal Cortical Carcinoma

Adrenal Gland Pheochromocytoma

Anal Canal Neuroendocrine Carcinoma

Anal Canal Undifferentiated Carcinoma

Angiosarcoma

Apocrine Neoplasm

Appendix Mucinous Adenocarcinoma

Bartholin Gland Transitional Cell Carcinoma

Basal Cell Carcinoma

Bladder Adenocarcinoma

Breast Metaplastic Carcinoma

Cervical Adenocarcinoma

Cholangiocarcinoma

Chordoma

Colorectal Squamous Cell Carcinoma

Desmoid Fibromatosis

Endometrial Transitional Cell Carcinoma

Endometrioid Adenocarcinoma

Esophageal Neuroendocrine Carcinoma

Esophageal Undifferentiated Carcinoma

Extrahepatic Bile Duct Carcinoma

Extramammary Paget Disease

Fallopian Tube Adenocarcinoma

Fallopian Tube Transitional Cell Carcinoma

Fibromyxoid Tumor

Gallbladder Carcinoma

Gastric Neuroendocrine Carcinoma

Gastric Squamous Cell Carcinoma

Gastric Undifferentiated Carcinoma

Gastrointestinal Stromal Tumor

Gestational Trophoblastic Tumor

Giant Cell Carcinoma

Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type

Intestinal Neuroendocrine Carcinoma

Intrahepatic Cholangiocarcinoma

Lung Neuroendocrine Tumor

Lung Sarcomatoid Carcinoma

Major Salivary Gland Carcinoma

Malignant Neoplasm of Unknown Primary

Malignant Odontogenic Neoplasm

Malignant Peripheral Nerve Sheath Tumor

Malignant Solid Neoplasm

Malignant Testicular Sex Cord-Stromal Tumor

Metastatic Pituitary Neuroendocrine Tumor

Minimally Invasive Lung Adenocarcinoma

Mixed Mesodermal (Mullerian) Tumor

Mucinous Adenocarcinoma

Mucinous Cystadenocarcinoma

Nasal Cavity Adenocarcinoma

Nasal Cavity Carcinoma

Nasopharyngeal Carcinoma

Nasopharyngeal Low Grade Papillary Adenocarcinoma

Nasopharyngeal Undifferentiated Carcinoma

Oral Cavity Carcinoma

Oropharyngeal Undifferentiated Carcinoma

Ovarian Adenocarcinoma

Ovarian Germ Cell Tumor

Ovarian Mucinous Adenocarcinoma

Ovarian Squamous Cell Carcinoma

Ovarian Transitional Cell Carcinoma

Pancreatic Acinar Cell Carcinoma

Pancreatic Neuroendocrine Carcinoma

Paraganglioma

Paranasal Sinus Adenocarcinoma

Paranasal Sinus Carcinoma

Parathyroid Gland Carcinoma

PEComa

Penile Squamous Cell Carcinoma

Peritoneal Mesothelial Neoplasm

Placental Choriocarcinoma

Primary Peritoneal High Grade Serous Adenocarcinoma

Pseudomyxoma Peritonei

Rare Disorder

Scrotal Squamous Cell Carcinoma

Seminal Vesicle Adenocarcinoma

Seminoma

Serous Cystadenocarcinoma

Small Intestinal Adenocarcinoma

Small Intestinal Squamous Cell Carcinoma

Spindle Cell Neoplasm

Teratoma With Somatic-Type Malignancy

Testicular Non-Seminomatous Germ Cell Tumor

Thyroid Gland Carcinoma

Tracheal Carcinoma

Transitional Cell Carcinoma

Ureter Adenocarcinoma

Ureter Squamous Cell Carcinoma

Urethral Adenocarcinoma

Urethral Squamous Cell Carcinoma

Vaginal Adenocarcinoma

Vaginal Squamous Cell Carcinoma, Not Otherwise Specified

Vulvar Carcinoma

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Data sourced from ClinicalTrials.gov