Study Summary
This trial is studying nivolumab and ipilimumab in treating patients with rare tumors.
Eligible Conditions
- Squamous Cell Carcinoma of the Colon and Rectum
- Ovarian Germ Cell Tumor
- Pancreatic Acinar Cell Carcinoma
- Ovarian Mucinous Adenocarcinoma
- Teratoma With Somatic-Type Malignancy
- Nasopharyngeal Cancer
- Penile Cancer
- Bladder Cancer
- Spindle Cell Tumor
- Penile Squamous Cell Carcinoma
- Breast Metaplastic Carcinoma
- Nasal Cavity Cancer
- Cholangiocarcinoma
- Metastatic Cancer of Unknown Primary
- Ovarian Cancer
- Peritoneal Mesothelioma
- Ovarian Squamous Cell Carcinoma
- Pituitary Gland Cancer
- Paranasal Sinus Cancer
- Tracheal Cancer
- Metastatic Pituitary Neuroendocrine Tumor
- Nasopharyngeal Adenocarcinoma
- Esophageal Undifferentiated Carcinoma
- Gastric Cancer
- Mucinous Adenocarcinoma
- Gallbladder Cancer
- Urethral Squamous Cell Carcinoma
- Peritoneal Mesotheliomas
- Nasopharyngeal Carcinoma
- Scrotal Cancer
- Placental Choriocarcinoma
- Serous Cystadenocarcinoma
- PEComas
- Seminal Vesicle Adenocarcinoma
- Major Salivary Gland Carcinoma
- Gastrointestinal Stromal Tumor
- Pancreatic Neuroendocrine Tumor
- Nasal Cavity Adenocarcinoma
- Gastric Squamous Cell Carcinoma
- Cancer
- Oropharyngeal Undifferentiated Carcinoma
- Odontogenic Cancer
- Fallopian Tube Cancer
- Gestational Trophoblastic Disease
- Ovarian Transitional Cell Carcinoma
- Parathyroid Cancer
- Pheochromocytoma
- Basal Cell Carcinoma
- Paranasal Sinus Adenocarcinoma
- Small Intestinal Cancer
- Testicular Non-Seminomatous Germ Cell Tumor
- Vaginal Adenocarcinoma
- Acinar Cell Carcinoma
- Gastric Neuroendocrine Carcinoma
- Paraganglioma
- Rare Disorders
- Oral Cancer
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Vaginal Squamous Cell Carcinoma
- Thyroid Cancer
- Malignant Peripheral Nerve Sheath Tumor
- Pseudomyxoma Peritonei
- Paget Disease of the Vulva
- Adrenal Cortical Carcinoma
- Apocrine Neoplasm
- Lung Sarcomatoid Carcinoma
- Cervical Adenocarcinoma
- Chordoma
- Esophageal Neuroendocrine Carcinoma
- Intestinal Neuroendocrine Carcinoma
- Intrahepatic Cholangiocarcinoma
- Malignant Testicular Sex Cord-Stromal Tumor
- Anal Canal Neuroendocrine Carcinoma
- Anal Canal Carcinoma
- Fibromyxoid Tumor
- Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type
- Lung Carcinoid Tumor
- Minimally Invasive Lung Adenocarcinoma
- Mixed Mullerian Tumor
- Giant Cell Carcinoma
- Mucinous Cystadenocarcinoma
- Ureter Adenocarcinoma
- Ureter Squamous Cell Carcinoma
- Urethral Adenocarcinoma
- Seminoma
- Vulvar Cancer
- Hemangiosarcoma
- Adrenal Cortex Cancer
- Appendix Mucinous Adenocarcinoma
- Bartholin Gland Carcinoma
- Desmoid Tumor
- Endometrial Transitional Cell Carcinoma
- Endometrioid Adenocarcinoma
- Bile Duct Cancer
- Adenoid Cystic Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Up to 10 years
6 months
Clinical benefit rate
Year 10
Overall survival (OS)
Year 10
Progression free survival (PFS)
Up to 10 years
Best response
Incidence of adverse events
Overall response rate (ORR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm I (nivolumab, ipilimumab)
1 of 2
Arm II (nivolumab)
1 of 2
Experimental Treatment
818 Total Participants · 2 Treatment Groups
Primary Treatment: Ipilimumab · No Placebo Group · Phase 2
Arm I (nivolumab, ipilimumab)Experimental Group · 3 Interventions: Ipilimumab, Biospecimen Collection, Nivolumab · Intervention Types: Biological, Procedure, Biological
Arm II (nivolumab)Experimental Group · 2 Interventions: Biospecimen Collection, Nivolumab · Intervention Types: Procedure, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Biospecimen Collection
2004
Completed Phase 1
~670
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,156 Previous Clinical Trials
41,162,788 Total Patients Enrolled
20 Trials studying Teratoma
37,784 Patients Enrolled for Teratoma
Sandip P PatelPrincipal InvestigatorSouthwest Oncology Group
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You previously had stage I or II cancer, but it is currently under control and you are in remission.
The group of participants with cancer from an unknown source is no longer accepting new members since 12/22/2017.
You had cancer in the past, but you have been free of it for at least one year.
You have a rare cancer and can provide tissue or blood samples for testing, except for those in the gestational trophoblastic disease cohort. If you have PD-L1 amplification, you may still be eligible for the study. If you were previously part of the NCI-Molecular Analysis for Therapy Choice (MATCH) study but did not receive a molecularly-guided treatment, you may also be eligible.
If you don't fit into any of the groups previously mentioned and aren't on the list of ineligible tumors, you may still be considered for the study's "Not Otherwise Categorized" rare tumors group, but you must get confirmation from at least one of the study chairs through email.
You have a rare form of cancer that cannot be identified where it originated from, but it has spread to other parts of your body.
You have tried at least one standard treatment for your condition but it did not work, and there is no other approved treatment available that has been proven to help you live longer. If you cannot receive other standard treatment due to medical reasons, you may still be eligible if you meet other criteria. If there is no standard treatment available for your condition, you may also be eligible.
You need to have a recent and accurate CT scan or MRI showing measurable disease. If there is a chance of bone metastasis, a bone scan may also be required. The scans should have been done within the last 28 or 42 days before registration.
The group for rare tumors that cannot be categorized was closed for enrollment on March 15, 2019 and is no longer accepting new participants.
If you have stage I or II follicular thyroid or prostate cancer that is being treated and under control, you may still participate in the study. You do not need to be completely cured of your cancer.
References
- Wagner, Michael J, Megan Othus, Sandip P Patel, Chris Ryan, Ashish Sangal, Benjamin Powers, G Thomas Budd, et al.. 2021. “Multicenter Phase II Trial (SWOG S1609, Cohort 51) of Ipilimumab and Nivolumab in Metastatic or Unresectable Angiosarcoma: A Substudy of Dual Anti-ctla-4 and Anti-pd-1 Blockade in Rare Tumors (DART)”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-002990.
- Dai, Congxin, Siyu Liang, Bowen Sun, and Jun Kang. 2020. “The Progress of Immunotherapy in Refractory Pituitary Adenomas and Pituitary Carcinomas”. Frontiers in Endocrinology. Frontiers Media SA. doi:10.3389/fendo.2020.608422.
- Patel, Sandip P., Megan Othus, Young Kwang Chae, Francis J. Giles, Donna E. Hansel, Preet Paul Singh, Annette Fontaine, et al.. 2020. “A Phase II Basket Trial of Dual Anti–ctla-4 and Anti–pd-1 Blockade in Rare Tumors (DART SWOG 1609) in Patients with Nonpancreatic Neuroendocrine Tumors”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-3356.
- Adams, Sylvia, Megan Othus, Sandip Pravin Patel, Kathy D. Miller, Rashmi Chugh, Scott M. Schuetze, Mary D. Chamberlin, et al.. 2022. “A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti–ctla-4 and Anti–pd-1 Blockade in Rare Tumors (DART, SWOG S1609)”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2182.
- Adams, Sylvia, Megan Othus, Sandip Pravin Patel, Kathy D. Miller, Rashmi Chugh, Scott M. Schuetze, Mary D. Chamberlin, et al.. 2022. “A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti–ctla-4 and Anti–pd-1 Blockade in Rare Tumors (DART, SWOG S1609)”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2182.
- Adams, Sylvia, Megan Othus, Sandip Pravin Patel, Kathy D. Miller, Rashmi Chugh, Scott M. Schuetze, Mary D. Chamberlin, et al.. 2022. “A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti–ctla-4 and Anti–pd-1 Blockade in Rare Tumors (DART, SWOG S1609)”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2182.
- Patel, Sandip Pravin, Edward Mayerson, Young Kwang Chae, Jonathan Strosberg, Jue Wang, Bhavana Konda, Jourdain Hayward, et al.. 2021. “A Phase II Basket Trial of Dual Anti–ctla–4 and Anti–pd–1 Blockade in Rare Tumors (DART) SWOG S1609: High‐grade Neuroendocrine Neoplasm Cohort”. Cancer. Wiley. doi:10.1002/cncr.33591.
- Wagner MJ, Othus M, Patel SP, Ryan C, Sangal A, Powers B, Budd GT, Victor AI, Hsueh CT, Chugh R, Nair S, Leu KM, Agulnik M, Sharon E, Mayerson E, Plets M, Blanke C, Streicher H, Chae YK, Kurzrock R. Multicenter phase II trial (SWOG S1609, cohort 51) of ipilimumab and nivolumab in metastatic or unresectable angiosarcoma: a substudy of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART). J Immunother Cancer. 2021 Aug;9(8):e002990. doi: 10.1136/jitc-2021-002990.
- Dai C, Liang S, Sun B, Kang J. The Progress of Immunotherapy in Refractory Pituitary Adenomas and Pituitary Carcinomas. Front Endocrinol (Lausanne). 2020 Dec 11;11:608422. doi: 10.3389/fendo.2020.608422. eCollection 2020.
- 2017. "Nivolumab and Ipilimumab in Treating Patients With Rare Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02834013.
Frequently Asked Questions
For what medical conditions is Ipilimumab commonly given?
"Ipilimumab can be used to treat conditions such as previous anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma." - Anonymous Online Contributor
Unverified Answer
Are there any metropolitan hospitals participating in this research project?
"Currently, this trial is being run at 100 different sites. They are situated in locations such as Fremont, Los Angeles and Ontario as well as 100 other places. It would be advantageous to choose the location nearest you to cut down on travel if you decide to participate." - Anonymous Online Contributor
Unverified Answer
Are there other medical studies that have used Ipilimumab as a treatment?
"Ipilimumab was first trialled in 2009 Texas Children's Hospital. Subsequently, there have been a total of 369 completed trials with 796 currently active trials; many of which are based out of Fremont, California." - Anonymous Online Contributor
Unverified Answer
What is the FDA's opinion of Ipilimumab?
"While there is some evidence to support the safety of Ipilimumab, it only received a score of 2 because this treatment is still in Phase 2 clinical trials." - Anonymous Online Contributor
Unverified Answer
Is there still room for more participants in this experiment?
"That is correct. The listing on clinicaltrials.gov indicates that this trial, which was first posted on January 13th 2017, has currently open recruitment and is looking for 818 patients at 100 different sites." - Anonymous Online Contributor
Unverified Answer