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Protocol Details

A Phase II Study of Ipilimumab, Cabozantinib, and NIvolumab in Rare Genitourinary Cancers (ICONIC)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-C-0137

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women;
Children

Keywords

Immune Therapy;
Anti-CTLA-4;
Receptor Tyrosine Kinases;
Anti PD-1;
Angiogenesis Inhibitor

Recruitment Keyword(s)

None

Condition(s)

Bladder Cancer;
Urothelial Cancer;
Penile Cancer;
Urogenital Cancer;
Sarcomatoid Renal Cell Carcinoma

Investigational Drug(s)

Nivolumab
Cabozantinib

Investigational Device(s)

None

Intervention(s)

Drug: Cabozantinib
Drug: Nivolumab
Drug: Ipilimumab

Supporting Site

National Cancer Institute

Background:

People can get rare genitourinary (GU) tumors in their kidney, bladder, ureters, penis, and other areas. Because these tumors are rare, there is no standard treatment option. Researchers want to see if a combination of drugs can shrink these tumors without significant side effects.

Objective:

To test the effectiveness of cabozantinib with nivolumab and ipilimumab in rare GU cancers that have no standard treatment options.

Eligibility:

Adults 18 and older with a rare, advanced GU tumor.

Design:

This study has 9 different groups based on a type of rare GU cancer and one group based on rare GU tumors with bone-only metastases.

Participants will be screened with a body scan and a bone scan if needed. They will give blood and urine samples. They will answer questions about their level of energy and functionality. Their heart s electrical activity will be monitored. Their tumor will be assessed on body scans. Most of these procedures will be repeated during the study.

Eligible participants will take cabozantinib by mouth daily. They will get nivolumab and ipilimumab in a vein every 3 weeks. After 12 weeks, participants will continue taking cabozantinib by mouth daily and will also get nivolumab every 4 weeks. Ipilimumab will only be given during the first 12 weeks. Cabozantinib and nivolumab can be given for up to 2 years after a response to therapy is achieved. They will keep a medicine diary.

Participants may have a tumor biopsy.

Participants will be followed for 100 days after they stop taking the study drugs. Then they will be contacted every 2 months until 5 years after they started the study.

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Eligibility

ELIGIBILITY CRITERIA:

- Patients must have a histologically confirmed diagnosis of metastatic: small cell/neuroendocrine carcinoma of the bladder; adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell carcinoma; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma; renal collecting duct carcinoma; bone only urothelial carcinoma or other non-prostate GU tumor - urethra carcinoma, or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC.

- Patients must have measurable disease (RECIST v. 1.1). Patients must have one bone lesion on bone scan for the bone-only cohort.

- Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment. Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)

- Age greater than or equal to 18 years

- Patients must not have had prior treatment with cabozantinib


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrea B. Apolo, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-0536
apoloab@mail.nih.gov

Tzu-Fang Wang, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3236
tzu-fang.wang@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03866382

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