Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

Study ID: 44641
Short Title: Pan tumor Nivolumab Rollover Study
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: SPCPS
Phase: II
Expected End Date: 31/12/2022
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

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. Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. 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 follow-up only. Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or 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. Male and female participants ages 18 and older.

Participant is not eligible for nivolumab treatment as per the Parent Study. Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only). 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. History of allergy or hypersensitivity to study drug components. 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.) Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation. Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the subject. Participants in survival follow-up have no exclusion criteria. Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria.

The purpose of this study is to collect the long-term safety and survival information in participants with different tumour types who will be provided nivolumab or have finished treatment and are now in or have completed follow-up on a Bristol-Myers Squibb (BMS) clinical research study (parent study). The Sponsor for this clinical research study is Bristol-Myers Squibb (BMS) There is not a specific number of patients participating. Enrolment in the study is on a rolling basis and is dependent on the patient’s status in the BMS clinical trial (parent study). Their participation may be either: • as a participant who is being treated with nivolumab from a previous BMS clinical trial. The study doctor will continue to assess long-term safety and survival information. • as a participant who is being followed for survival or has completed follow-up from a previous BMS clinical study, having completed, discontinued, or progressed on treatment, and/or on another therapy. The study doctor will continue to assess long-term safety and survival. This study is being conducted at multiple clinical sites in the United Kingdom and Europe.

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