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OpenTrials
Completed

NCT Number: NCT03656718

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

* non-small cell lung cancer (NSCLC) * renal cell carcinoma (RCC) * unresectable or metastatic melanoma * hepatocellular carcinoma (HCC) * microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) * in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician * In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

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Key information

Conditions

Neoplasms by Site Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0025, CABA, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
  • Metastatic squamous or non-squamous NSCLC
  • RCC, advanced or metastatic
  • Melanoma
  • HCC
  • CRC, metastatic (MSI-H or dMMR)
  • In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
  • In Part E, Metastatic urothelial carcinoma
  • Measurable disease as per RECIST version 1.1 criteria
  • ECOG performance status of 0 or 1

Exclusion criteria

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

Nivolumab

Biological

(Subcutaneous) Specified dose on specified days

Other names: Opdivo, BMS-986298

rHuPH20

Drug

Specified dose on specified days Permeation enhancer

Other names: ENHANZE™ DP

Primary outcomes

  1. Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E

    Time frame: From first dose until approximately 21 days post first dose.

    Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

  2. Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E

    Time frame: From first dose until approximately 21 days post first dose.

    Tmax is the time taken to reach the maximum observed serum nivolumab concentration (Cmax). Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

  3. Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E

    Time frame: From first dose until approximately 21 days post first dose.

    AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

  4. Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E

    Time frame: At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)

    Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.

  5. Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C

    Time frame: On Day 1 of Cycles 2, 3, 5, 9, 13, and 19 of Part C (Day 1 of Part C: up to 14 months from Baseline; each cycle was 28 days)

    Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From first dose until 100 days post last dose (up to approximately 70 months).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  2. Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)

    Time frame: From first dose until 100 days post last dose (up to approximately 70 months).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.

  3. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: From first dose until 100 days post last dose (up to approximately 70 months).

    A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization.

  4. Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)

    Time frame: From first dose until 100 days post last dose (up to approximately 70 months).

    A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization. TRSAEs are SAEs where a reasonable causal relationship exists between study treatment administration and the SAE.

  5. Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation

    Time frame: From first dose until 100 days post last dose (up to approximately 70 months).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.

  6. Number of Participants Who Died

    Time frame: From randomization until data cutoff (up to approximately 70 months).

    Number of participants who died due to any cause.

  7. Number of Participants With Select Laboratory Changes From Baseline

    Time frame: From first dose until 30 days post last dose (up to approximately 67 months and 20 days).

    Laboratory parameters including hematology, chemistry, liver function, and renal function summarized using worst grade NCI CTCAE v.5 criteria. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.

  8. Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration

    Time frame: From first dose until 2 days post last dose (up to approximately 66 months and 22 days).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  9. Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies

    Time frame: At baseline and up to 100 days post last dose (up to approximately 70 months).

    Anti-drug antibody (ADA) Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment; Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline.

    Baseline ADA Positive: A participant with a baseline ADA-positive sample. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Sep 4, 2018
Registry last updated
Nov 12, 2025

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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