Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02834013|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acinar Cell Carcinoma Adenoid Cystic Carcinoma Adrenal Cortex Carcinoma Adrenal Gland Pheochromocytoma Anal Canal Neuroendocrine Carcinoma Anal Canal Undifferentiated Carcinoma Appendix Mucinous Adenocarcinoma Bartholin Gland Transitional Cell Carcinoma Bladder Adenocarcinoma Cervical Adenocarcinoma Cholangiocarcinoma Chordoma Colorectal Squamous Cell Carcinoma Desmoid-Type Fibromatosis Endometrial Transitional Cell Carcinoma Endometrioid Adenocarcinoma Esophageal Neuroendocrine Carcinoma Esophageal Undifferentiated Carcinoma Extrahepatic Bile Duct Carcinoma Fallopian Tube Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Fibromyxoid Tumor Gastric Neuroendocrine Carcinoma Gastric Squamous Cell Carcinoma Gastrointestinal Stromal Tumor Giant Cell Carcinoma Intestinal Neuroendocrine Carcinoma Intrahepatic Cholangiocarcinoma Lung Carcinoid Tumor Lung Sarcomatoid Carcinoma Major Salivary Gland Carcinoma Malignant Odontogenic Neoplasm Malignant Peripheral Nerve Sheath Tumor Malignant Testicular Sex Cord-Stromal Tumor Metaplastic Breast Carcinoma Metastatic Malignant Neoplasm of Unknown Primary Origin Minimally Invasive Lung Adenocarcinoma Mixed Mesodermal (Mullerian) Tumor Mucinous Adenocarcinoma Mucinous Cystadenocarcinoma Nasal Cavity Adenocarcinoma Nasal Cavity Carcinoma Nasopharyngeal Carcinoma Nasopharyngeal 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 Pituitary Gland Carcinoma Placental Choriocarcinoma Placental-Site Gestational Trophoblastic Tumor 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 Squamous Cell Carcinoma of the Penis Teratoma With Malignant Transformation Testicular Non-Seminomatous Germ Cell Tumor Thyroid Gland Carcinoma Tracheal Carcinoma Transitional Cell Carcinoma Undifferentiated Gastric Carcinoma Ureter Adenocarcinoma Ureter Squamous Cell Carcinoma Urethral Adenocarcinoma Urethral Squamous Cell Carcinoma Vaginal Adenocarcinoma Vaginal Squamous Cell Carcinoma, Not Otherwise Specified Vulvar Carcinoma||Procedure: Biospecimen Collection Biological: Ipilimumab Biological: Nivolumab||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||707 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors|
|Actual Study Start Date :||January 13, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
Experimental: Treatment (nivolumab, ipilimumab)
Patients receive nivolumab 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.
Procedure: Biospecimen Collection
Undergo optional collection of biopsy tissue and bloodBiological: Ipilimumab
Other Names:Biological: Nivolumab
- Overall response rate (ORR) defined as confirmed and unconfirmed complete and partial response [ Time Frame: Up to 10 years ]Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Incidence of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 10 years ]Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
- Best response calculated from the sequence of RECIST 1.1 and immune-related response criteria (irRC) objectives [ Time Frame: Up to 10 years ]Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
- Clinical benefit rate defined as complete response, partial response, or stable disease, estimated using both RECIST and irRC [ Time Frame: 6 months ]Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
- Overall survival (OS), estimated using both RECIST and irRC [ Time Frame: From date of registration to date of death due to any cause, assessed up to 10 years ]
- Progression free survival (PFS), estimated using both RECIST and irRC [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration or death, assessed up to 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834013
Show 805 Study Locations
|Principal Investigator:||Sandip Patel||Southwest Oncology Group|