A trial to determine the clinical benefit of administering Nivolumab in patients with advanced cancer and/or cancer that has spread to other sites in the body
- Conditions
- Advanced/Metastatic malignanciesMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000461-23-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 350
1) Cohorts are comprised of tumor types which may include the following advanced or metastatic malignancies:
1. Adenocarcinoma of the small bowel
2. Adrenocortical carcinoma
3. adenoid cystic carcinoma
4. anal cancer
5. biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma gallbladder cancer, ampullary carcinoma)
6. carcinoid after somatostatin analogs (SSA) (Ki67 less than 20%)
7. cervix cancer (exocervix, squamous cell pathology)
8. endometrial cancer (after primary treatment that includes radiation therapy. Subjects with tumors greater than 10% estrogen receptor positive pathology in the primary tumor are excluded)
9. histiocytoses (including Erdheim Chester disease, Langerhans cell histiocytosis)
10. insulinoma
11. Lynch syndrome associated cancers (excluding hereditary nonpolyposis colorectal cancer [HNPCC]).
12. medullary thyroid cancer
13. Merkel cell carcinoma (includes unresectable disease)
14. nasopharyngeal carcinoma
15. neuroendocrine tumors (poorly differentiated, Ki67 greater than 20%)
16. neuroendocrine tumors (well to moderately differentiated, Ki67 less than 20%)
17. non-lung small cell carcinoma (including small cell carcinoma of the ovary of pulmonary type or small cell ovarian cancer hypercalcemic type)
18. non squamous cell cancer of the head and neck (including cancer of the salivary gland)
19. penile cancer
20. rare women's cancers (high grade, clear cell: greater than 50% clear cell by pathology)
21. soft-tissue sarcoma (including liposarcoma, leiomyosarcoma)
22. malignant peripheral nerve sheath tumor-NF-1
23. testicular cancer (chemotherapy resistant or recurrent within 2 years of primary therapy)
24. thymic carcinoma or invasive thymoma
25. thyroid cancer (anaplastic thyroid cancer as primary therapy)
26. thyroid cancer (papillary or follicular, after failing radioactive iodine [RAI] and after approved kinase inhibition [lenvatinib])
27. uterine sarcoma (excluding endometrial stroma sarcoma)
28. vaginal cancer (squamous cell pathology)
29. vulvar cancer (squamous cell pathology)
2) Adults = 18 years of age
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4) Pathology report confirming diagnosis of malignancy. Subjects will have advanced or metastatic disease. In the case of anaplastic thyroid cancer, subjects may receive nivolumab as part of primary therapy.
5) Subjects must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST)
6) Subjects must have received standard-of-care primary treatment for malignancy and standard-of-care for relapse or refractory disease, if treatment exists. For de novo metastatic disease subjects with recurrent or refractory disease after standard-of-care (first-line therapy or second-line [if treatment exists]) will be eligible for this trial. If there is no standard-of-care treatment for de novo metastatic disease (eg, metastatic carcinoid), subjects are eligible to enroll without prior first-line (or second-line) therapy.
7) Mandatory tissue and blood collection for PD-L1 testing and MMR-deficiency testing. Tumor tissue (formalinfixed, paraffin embedded archival [< 3 months old] or recent acquisition) must be received by a central laboratory before first treatment. In order to receive treatment, the sample must meet the minimum quality requirements, as determined by the central laboratory. If the archival tissue is
1) Subjects who require ongoing treatment with more than 10 mg of prednisone (or steroid equivalent, excluding inhaled or topical steroids) daily
2) Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
3) Subjects with the following malignancies are excluded:
1. adenocarcinoma of the colon
2. adenocarcinoma of the prostate
3. adenocarcinoma of the rectum
4. meningioma (low grade)
5. peritoneal carcinoma
6. primary CNS lymphoma
7. squamous cell carcinoma of the head and neck
8. squamous cell carcinoma of the skin
9. carcinoma of unknown primary
4) Subjects with an active, known, or suspected autoimmune disease (Subjects may enroll with type I diabetes mellitus, hypothyroidism [only requiring hormone replacement], vitiligo, psoriasis, or alopecia not requiring systemic treatment.)
5) Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method