Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma
- Conditions
- Pediatric malignant solid tumors, Hodgkin lymphoma
- Registration Number
- JPRN-UMIN000026497
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Not provided
1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years) 2)Infection requiring systemic therapy 3)Active gastrointestinal ulceration 4)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy) 5)Current or previous severe hypersensitive reaction to medicines 6)Currently active or previously chronic or recurrent auto immune disease (except for type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disorder requiring no systemic therapy, and any auto immune disease expected not to relapse without external factors) 7)HIV antibody-positive, or HTLV-1 antibody-positive, or HBs antigen-positive, or HCV antibody-positive (except for HCV-RNA-negative even if HCV antibody-positive) 8)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Psychiatric diseases or psychological symptoms interfering with participation in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse effects equivalent to dose-limiting toxicity
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Safety Overall response rate Progression-free survival Overall survival