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Needle under the skin: easier nivolumab shot studied for advanced tumors

NCT ID NCT03656718

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested giving the cancer drug nivolumab as a shot under the skin (instead of through an IV) to people with advanced cancers like lung, kidney, melanoma, liver, and colorectal cancer. The main goal was to see how the drug moves in the body and to check for side effects. 139 participants took part, and the results help doctors understand if this easier method works as well as the standard IV infusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

139 people

The number who actually took part.

Started

Oct 2018

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: 1. Metastatic squamous or non-squamous NSCLC 2. RCC, advanced or metastatic 3. Melanoma 4. HCC 5. CRC, metastatic (MSI-H or dMMR) 6. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor 7. 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

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Conditions

The condition(s) this trial relates to.

colorectal cancer hepatocellular carcinoma melanoma metastatic melanoma Neoplasms by Site non-small cell lung carcinoma renal cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms by site

Contacts and locations

Locations

  • Greenville Health System

    Greenville, South Carolina, 29605, United States

  • Local Institution - 0001

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 0003

    Rozzano, MI, 20089, Italy

  • Local Institution - 0004

    Padova, 35128, Italy

  • Local Institution - 0005

    Santiago, 0, Chile

  • Local Institution - 0007

    Dallas, Texas, 75246, United States

  • Local Institution - 0009

    Beaumont, Texas, 77702-1449, United States

  • Local Institution - 0010

    Austin, Texas, 78705, United States

  • Local Institution - 0011

    Tyler, Texas, 75702, United States

  • Local Institution - 0012

    Eugene, Oregon, 97401, United States

  • Local Institution - 0014

    Dunedin, 9012, New Zealand

  • Local Institution - 0015

    Tauranga, 3112, New Zealand

  • Local Institution - 0016

    Málaga, 29010, Spain

  • Local Institution - 0017

    Madrid, 28007, Spain

  • Local Institution - 0018

    Newtown, Wellington Region, 6021, New Zealand

  • Local Institution - 0019

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Local Institution - 0020

    Detroit, Michigan, 48201-2014, United States

  • Local Institution - 0021

    Villejuif, 94805, France

  • Local Institution - 0022

    Saint-Herblain, 44805, France

  • Local Institution - 0024

    Rockville, Maryland, 20850, United States

  • Local Institution - 0025

    CABA, 1426, Argentina

  • Local Institution - 0026

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Local Institution - 0031

    Liverpool, L7 8YA, United Kingdom

  • Local Institution - 0033

    Cardiff, Glamorgan, CF14 2TL, United Kingdom

  • Local Institution - 0035

    CABA, 1199, Argentina

  • Local Institution - 0037

    São Paulo, 05651-901, Brazil

  • Local Institution - 0038

    Porto Alegre, Rio Grande do Sul, 90610000, Brazil

  • Local Institution - 0039

    Maastricht, 6229 HX, Netherlands

  • Local Institution - 0040

    Rotorua, Bay of Plenty, 3046, New Zealand

  • Local Institution - 0045

    Querétaro, 76000, Mexico

  • Local Institution - 0046

    Monterrey, Nuevo León, 64710, Mexico

  • Local Institution - 0047

    Monterrey, Nuevo León, 66460, Mexico

  • Local Institution - 0048

    Mexico City, Mexico City, 14080, Mexico

  • Local Institution - 0049

    Puebla City, 72424, Mexico

  • Local Institution - 0050

    Mexico City, Mexico City, 03100, Mexico

  • Winship Cancer Institute.

    Atlanta, Georgia, 30322, United States

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