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Completed

NCT Number: NCT03745807

An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.

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Key information

Conditions

Advanced Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.1.
  • Life expectancy >12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

  • Active, known or suspected autoimmune disease.
  • History of organ transplant that requires use of immune suppressive agents.
  • Prior surgery or radiotherapy within 14 days of Cycle 1 Day 1. Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

NKTR-214

Biological

Specified dose on specified days

Other names: Bempegaldesleukin, BMS-986321

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Approximately 2 years

  2. Incidence of serious adverse events (SAEs)

    Time frame: Approximately 2 years

  3. Incidence of AEs leading to discontinuation

    Time frame: Approximately 2 years

  4. Incidence of deaths

    Time frame: Approximately 2 years

  5. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria

    Time frame: Approximately 2 years

  6. Incidence of laboratory abnormalities

    Time frame: Approximately 2 years

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Approximately 2 years

  2. Time of maximum observed concentration (Tmax)

    Time frame: Approximately 2 years

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Approximately 2 years

  4. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Approximately 2 years

  5. Total body clearance (CLT)

    Time frame: Approximately 2 years

  6. Volume of distribution (Vz)

    Time frame: Approximately 2 years

  7. Apparent terminal phase half-life (T-HALF)

    Time frame: Approximately 2 years

  8. Trough observed serum concentration at the end of the dosing interval (Ctrough)

    Time frame: Approximately 2 years

  9. Incidence of anti-drug antibodies (ADA) to NKTR-214

    Time frame: Approximately 2 years

  10. Incidence of anti-drug antibodies (ADA) to nivolumab

    Time frame: Approximately 2 years

  11. Best overall response (BOR)

    Time frame: Approximately 2 years

  12. Duration of response (DOR)

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Nektar Therapeutics
  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2018
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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