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Clinical Trials List

Protocol NumberCA2098TT
NCT Number(ClinicalTrials.gov Identfier)NCT03899155
Active

2020-11-01 - 2030-08-22

Phase II

Recruiting4

ICD-10C00.0

Malignant neoplasm of external upper lip

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9140.0

Malignant neoplasm of upper lip, vermilion border

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

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YU-YUN SHAO

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Cancer

Objectives

Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

Test Drug

Nivolumab

Active Ingredient

Nivolumab

Dosage Form

Injection

Dosage

10 mg/ml

Endpoints

1.Incidence of Adverse Events (AEs)
2.Incidence of drug related AEs
3.Incidence of AEs leading to Discontinuation
4.Incidence of Serious Adverse Events (SAEs)
5.Incidence of Select AEs
6.Incidence of Immune-Mediated AEs
7.Incidence of Death

Inclution Criteria

1.Signed Written Informed Consent
2.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.
3.Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or
4.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

Exclusion Criteria

1.Participant is not eligible for nivolumab treatment as per the Parent Study
2.Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)
3.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.Participants in survival follow-up have no exclusion criteria.

The Estimated Number of Participants

  • Taiwan

    5 participants

  • Global

    1200 participants