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:
- 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)
- Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
- Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual)
- Undifferentiated carcinoma of gastrointestinal (GI) tract
- Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
- Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018)
- Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018)
- Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual)
- Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
- Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
- Sarcomatoid carcinoma of lung
- Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma
- Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018)
- Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
- Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual)
- 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)
- Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual)
- Squamous cell carcinoma variants of the genitourinary (GU) system
- Spindle cell carcinoma of kidney, pelvis, ureter
- Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018)
- Odontogenic malignant tumors
- Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual)
- Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
- Pheochromocytoma, malignant (closed to accrual)
- Paraganglioma (closed to accrual 11/29/2018)
- Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual)
- Desmoid tumors
- Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
- Malignant giant cell tumors
- Chordoma (closed to accrual 11/29/2018)
- Adrenal cortical tumors (closed to accrual 06/27/2018)
- Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
- 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)
- Adenoid cystic carcinoma (closed to accrual 02/06/2018)
- Vulvar cancer (closed to accrual)
- MetaPLASTIC carcinoma (of the breast) (closed to accrual)
- Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
- Perivascular epithelioid cell tumor (PEComa)
- Apocrine tumors/extramammary Paget's disease (closed to accrual)
- Peritoneal mesothelioma
- Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
- Clear cell cervical cancer
- Esthenioneuroblastoma (closed to accrual)
- Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
- Clear cell endometrial cancer
- Clear cell ovarian cancer (closed to accrual)
- Gestational trophoblastic disease (GTD)
- Gallbladder cancer
- Small cell carcinoma of the ovary, hypercalcemic type
- PD-L1 amplified tumors
- Angiosarcoma
- 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)
- 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:
- 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)
- Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
- Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual)
- Undifferentiated carcinoma of gastrointestinal (GI) tract
- Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
- Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018)
- Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018)
- Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual)
- Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
- Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
- Sarcomatoid carcinoma of lung
- Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma
- Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018)
- Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
- Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual)
- 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)
- Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual)
- Squamous cell carcinoma variants of the genitourinary (GU) system
- Spindle cell carcinoma of kidney, pelvis, ureter
- Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018)
- Odontogenic malignant tumors
- Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual)
- Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
- Pheochromocytoma, malignant (closed to accrual)
- Paraganglioma (closed to accrual 11/29/2018)
- Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual)
- Desmoid tumors
- Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
- Malignant giant cell tumors
- Chordoma (closed to accrual 11/29/2018)
- Adrenal cortical tumors (closed to accrual 06/27/2018)
- Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
- 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)
- Adenoid cystic carcinoma (closed to accrual 02/06/2018)
- Vulvar cancer (closed to accrual)
- MetaPLASTIC carcinoma (of the breast) (closed to accrual)
- Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
- Perivascular epithelioid cell tumor (PEComa)
- Apocrine tumors/extramammary Paget's disease (closed to accrual)
- Peritoneal mesothelioma
- Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
- Clear cell cervical cancer
- Esthenioneuroblastoma (closed to accrual)
- Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
- Clear cell endometrial cancer
- Clear cell ovarian cancer (closed to accrual)
- Gestational trophoblastic disease (GTD)
- Gallbladder cancer
- Small cell carcinoma of the ovary, hypercalcemic type
- PD-L1 amplified tumors
- Angiosarcoma
- 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)
- 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.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov