JPRN-UMIN000022007
Completed
Phase 2
Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial - Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma
ational Cancer Center0 sites15 target enrollmentJune 1, 2016
Conditionsthymic carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- thymic carcinoma
- Sponsor
- ational Cancer Center
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Patients with active double cancer (except for completely resected basal cell cancer, stage I squamous cell cancer, carcinoma in situ, intramucosal cancer, superficial bladder cancer, or gastrointestinal cancer resected by ESD or EMR, or other cancer free of relapse for 5 years) 2\)Patients who have an infection requiring systematic therapy 3\)Patients with active gastrointestinal ulceration 4\)Patients with current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings 5\)Patients with a current or previous severe hypersensitive reaction to an antibody product 6\)Patients with a current or chronic and recurrent auto immune disease (Patients could be enrolled if they had type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorder requiring no systematic therapy, or an auto immune disease predicted to remain free of disease in the absence of external factors) 7\)Patients who are HIV antibody\-positive, HBsAg\-positive, or HCV antibody\-positive (even though a patient was HCV antibody\-positive, the patient could be enrolled if the patient was HCV\-RNA\-negative) 8\)Patients who are HBsAg\-negative, but HBs antibody\-positive or HBc antibody\-positive, and HCV\-DNA quantitative test is positive 9\)Pregnant or breast\-feeding women, or women suspected of being pregnant 10\)Patients with a psychiatric disease or psychological symptoms
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial)clear cell sarcoma and alveolar soft part sarcomaJPRN-UMIN000023665ational Cancer Center20
Active, not recruiting
Phase 1
Treatment of advanced lung cancerPatients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and patients with Small cell lung cancer (SCLC) after failure of platinum-based first-line therapy.MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2016-003334-25-DEniversity of Cologne90
Active, not recruiting
Phase 1
A randomised phase II trial comparing two different ways of combining nivolumab and ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma.Previously untreated metastatic clear cell renal cell carcinoma.MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-001476-33-GBniversity of Leeds189
Active, not recruiting
Phase 1
A study of nivolumab in participants with metastatic or unresectable bladder cancermetastatic or unresectable urothelial cancerMedDRA version: 19.0Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10046728Term: Urothelial carcinoma urethraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-003625-17-SEBristol-Myers Squibb International Corporation323
Active, not recruiting
Phase 1
A study of nivolumab in participants with metastatic or unresectable bladder cancermetastatic or unresectable urothelial cancerMedDRA version: 20.0Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10046728Term: Urothelial carcinoma urethraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-003625-17-BEBristol-Myers Squibb International Corporation323