Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Bristol-Myers Squibb
Registry number NCT04895709
Started 27 May 2021 Today 16 October 2026 Estimated completion 31 August 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Blacktown Hospital Blacktown NSW Recruiting
Liverpool Hospital Liverpool NSW Recruiting
Princess Alexandra Hospital Brisbane QLD Recruiting
Cabrini Hospital - Malvern Malvern VIC Recruiting
St Vincent's Hospital Melbourne VIC Recruiting
One Clinical Research Nedlands WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1109

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria

* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.

* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.

* Eastern Cooperative Oncology Group Performance Status of 0 or 1.

* Radiographically documented progressive disease on or after the most recent therapy.

* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.

* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

Exclusion Criteria

* Women who are pregnant or breastfeeding.

* Primary central nervous system (CNS) malignancy.

* Untreated CNS metastases.

* Leptomeningeal metastases.

* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.

* Active, known, or suspected autoimmune disease.

* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.

* Prior organ or tissue allograft.

* Uncontrolled or significant cardiovascular disease.

* Major surgery within 4 weeks of study drug administration.

* History of or with active interstitial lung disease or pulmonary fibrosis.

* Other protocol-defined inclusion/exclusion criteria apply.

Dates on the record

Started 27 May 2021
Estimated completion 31 August 2031
Registry last updated 17 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 17 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.