Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
334

Summary

Conditions
  • Cholangiocarcinoma
  • Adrenal Cortex Carcinoma
  • Acinar Cell Carcinoma
  • Cervical Clear Cell Adenocarcinoma
  • Seminal Vesicle Adenocarcinoma
  • Gastrointestinal Stromal Tumor
  • Ureter Squamous Cell Carcinoma
  • Transitional Cell Carcinoma
  • Nasopharyngeal Papillary Adenocarcinoma
  • Adenoid Cystic Carcinoma
  • Adrenal Gland Pheochromocytoma
  • Cervical Adenocarcinoma
  • Oral Cavity Carcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Serous Cystadenocarcinoma
  • Anal Canal Neuroendocrine Carcinoma
  • Metastatic Malignant Neoplasm of Unknown Primary
  • Breast Metaplastic Carcinoma
  • Desmoid Fibromatosis
  • Ovarian Adenocarcinoma
  • Minimally Invasive Lung Adenocarcinoma
  • Fibromyxoid Tumor
  • Mixed Mesodermal (Mullerian) Tumor
  • Pituitary Gland Carcinoma
  • Lung Sarcomatoid Carcinoma
  • Anal Canal Undifferentiated Carcinoma
  • Placental Choriocarcinoma
  • Extrahepatic Bile Duct Carcinoma
  • Angiosarcoma
  • Gastric Neuroendocrine Carcinoma
  • Paraganglioma
  • Intrahepatic Cholangiocarcinoma
  • Ovarian Germ Cell Tumor
  • Malignant Odontogenic Neoplasm
  • Mucinous Adenocarcinoma
  • Oropharyngeal Undifferentiated Carcinoma
  • Lung Carcinoid Tumor
  • Gestational Trophoblastic Tumor
  • Giant Cell Carcinoma
  • Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
  • Vulvar Carcinoma
  • Endometrioid Adenocarcinoma
  • Malignant Solid Neoplasm
  • Parathyroid Gland Carcinoma
  • Urethral Adenocarcinoma
  • Ovarian Squamous Cell Carcinoma
  • Apocrine Neoplasm
  • Scrotal Squamous Cell Carcinoma
  • Paranasal Sinus Adenocarcinoma
  • Rare Disorder
  • Esophageal Neuroendocrine Carcinoma
  • Paranasal Sinus Carcinoma
  • Esophageal Undifferentiated Carcinoma
  • Appendix Mucinous Adenocarcinoma
  • Bartholin Gland Transitional Cell Carcinoma
  • Colorectal Squamous Cell Carcinoma
  • Thyroid Gland Carcinoma
  • Small Intestinal Adenocarcinoma
  • Malignant Testicular Sex Cord-Stromal Tumor
  • Pancreatic Neuroendocrine Carcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Gastric Undifferentiated Carcinoma
  • Spindle Cell Neoplasm
  • Urethral Squamous Cell Carcinoma
  • Chordoma
  • Vaginal Adenocarcinoma
  • Nasal Cavity Carcinoma
  • Pancreatic Acinar Cell Carcinoma
  • Major Salivary Gland Carcinoma
  • Nasal Cavity Adenocarcinoma
  • Gallbladder Carcinoma
  • Ureter Adenocarcinoma
  • PEComa
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Gastric Squamous Cell Carcinoma
  • Basal Cell Carcinoma
  • Testicular Non-Seminomatous Germ Cell Tumor
  • Fallopian Tube Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Teratoma With Somatic-Type Malignancy
  • Pseudomyxoma Peritonei
  • Seminoma
  • Endometrial Transitional Cell Carcinoma
  • Nasopharyngeal Undifferentiated Carcinoma
  • Squamous Cell Carcinoma of the Penis
  • Mucinous Cystadenocarcinoma
  • Nasopharyngeal Carcinoma
  • Intestinal Neuroendocrine Carcinoma
  • Small Intestinal Squamous Cell Carcinoma
  • Peritoneal Mesothelioma
  • Tracheal Carcinoma
  • Malignant Peripheral Nerve Sheath Tumor
  • Extramammary Paget Disease
  • Bladder Adenocarcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. II. To evaluate the overall response rate (ORR) ...

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. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with ipilimumab plus nivolumab combination immunotherapy. III. To evaluate the RECIST v1.1 overall response rate (ORR) in patients PD-L1 amplified cancers treated with nivolumab 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 (i)RECIST ORR (iORR), and iRECIST PFS (iPFS) across cohorts and within each cohort. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (ALL COHORTS EXCEPT THE PD-L1 AMPLIFIED COHORT): Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who complete 17 cycles (2 years) of therapy, may continue receiving the same treatment with nivolumab and ipilimumab, or receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) per physician discretion in the absence of disease progression or unacceptable toxicity. Patients who stop treatment prior to the completion of 17 cycles of therapy may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. ARM II (PD-L1 AMPLIFIED COHORT): Patients receive nivolumab IV over 30 minutes on days 1, 15 and 29. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After 17 cycles (2 years) of therapy, patients may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 10 years from registration.

Tracking Information

NCT #
NCT02834013
Collaborators
Not Provided
Investigators
Principal Investigator: Sandip P Patel Southwest Oncology Group