PAN TUMOR STUDY FOR LONG TERM FOLLOW-UP OF CANCER SURVIVORS WHO HAVE PARTICIPATED IN TRIALS INVESTIGATING NIVOLUMAB

Not Applicable

Recruiting

• Conditions: -C04 Malignant neoplasm of floor of mouth; Malignant neoplasm of floor of mouth; C04

• Registration Number: PER-044-20
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-08
• Study Completion: 2021-06-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

1. Signed Written Informed Consent
a) Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal participant care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
c) Participants who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity, in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival followup only.
2. Type of Participant
a) Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or
b) Participant is in or has completed the follow-up phase of the Parent Study
i) Participant has completed or discontinued treatment, or
ii) Participant has progressed on treatment, and/or
iii) Participant is on subsequent therapy
3. Age and Reproductive Status
a) Male and female participants ages 18 and older

Exclusion Criteria

1. Medical Conditions
a) Participant is not eligible for nivolumab treatment as per the Parent Study
2. Prior/Concomitant Therapy
a) Not applicable
3. Physical and Laboratory Test Findings
a) Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)
b) Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
4. Allergies and Adverse Drug Reaction
a) History of allergy or hypersensitivity to study drug components
5. Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions
apply and Bristol-Myers Squibb approval is required.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
c) Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation
d) Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified