Purpose

Category

IRB Number
20170145HU
NCT Number
NCT02834013
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu

Principal Investigator
Adolfo Diaz Duque

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Non-Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Acinar Cell Carcinoma
    2. Adenoid Cystic Carcinoma
    3. Adrenal Cortex Carcinoma
    4. Adrenal Gland Pheochromocytoma
    5. Anal Canal Neuroendocrine Carcinoma
    6. Anal Canal Undifferentiated Carcinoma
    7. Angiosarcoma
    8. Apocrine Neoplasm
    9. Appendix Mucinous Adenocarcinoma
    10. Bartholin Gland Transitional Cell Carcinoma
    11. Basal Cell Carcinoma
    12. Bladder Adenocarcinoma
    13. Breast Metaplastic Carcinoma
    14. Cervical Adenocarcinoma
    15. Cervical Clear Cell Adenocarcinoma
    16. Cholangiocarcinoma
    17. Chordoma
    18. Colorectal Squamous Cell Carcinoma
    19. Desmoid Fibromatosis
    20. Endometrial Transitional Cell Carcinoma
    21. Endometrioid Adenocarcinoma
    22. Esophageal Neuroendocrine Carcinoma
    23. Esophageal Undifferentiated Carcinoma
    24. Extrahepatic Bile Duct Carcinoma
    25. Extramammary Paget Disease
    26. Fallopian Tube Adenocarcinoma
    27. Fallopian Tube Transitional Cell Carcinoma
    28. Fibromyxoid Tumor
    29. Gallbladder Carcinoma
    30. Gastric Neuroendocrine Carcinoma
    31. Gastric Squamous Cell Carcinoma
    32. Gastric Undifferentiated Carcinoma
    33. Gastrointestinal Stromal Tumor
    34. Gestational Trophoblastic Tumor
    35. Giant Cell Carcinoma
    36. Intestinal Neuroendocrine Carcinoma
    37. Intrahepatic Cholangiocarcinoma
    38. Lung Carcinoid Tumor
    39. Lung Sarcomatoid Carcinoma
    40. Major Salivary Gland Carcinoma
    41. Malignant Odontogenic Neoplasm
    42. Malignant Peripheral Nerve Sheath Tumor
    43. Malignant Solid Neoplasm
    44. Malignant Testicular Sex Cord-Stromal Tumor
    45. Metastatic Malignant Neoplasm of Unknown Primary
    46. Minimally Invasive Lung Adenocarcinoma
    47. Mixed Mesodermal (Mullerian) Tumor
    48. Mucinous Adenocarcinoma
    49. Mucinous Cystadenocarcinoma
    50. Nasal Cavity Adenocarcinoma
    51. N

      52. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm II (nivolumab)

      		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.
    52. Procedure: Biospecimen Collection

      Undergo optional collection of biopsy tissue and blood

    53. Biological: Nivolumab

      Given IV

      Other names:

      • BMS-936558
      • MDX-1106
      • NIVO
      • ONO-4538
      • Opdivo

      54. Experimental

      Arm I (nivolumab, ipilimumab)

      		Patients receive nivolumab 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.
    54. Biological: Ipilimumab

      Given IV

      Other names:

      • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
      • BMS-734016
      • Ipilimumab Biosimilar CS1002
      • MDX-010
      • MDX-CTLA4
      • Yervoy

    55. Procedure: Biospecimen Collection

      Undergo optional collection of biopsy tissue and blood

    56. Biological: Nivolumab

      Given IV

      Other names:

      • BMS-936558
      • MDX-1106
      • NIVO
      • ONO-4538
      • Opdivo

      57.