Phase 2 Bladder Cancer Trial, Completed NCT03785925 Sponsor: Nektar Therapeutics Condition: Bladder Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 188 people, all of whom received a combination of two drugs — bempegaldesleukin (also called NKTR-214) and nivolumab. Of those, 172 completed the study and 16 did not. The trial was primarily looking at what is called the "objective response rate" (ORR) — that is, the proportion of participants whose tumours showed a meaningful reduction in size, either disappearing completely or shrinking by at least 30% — specifically in people whose tumours had low levels of a protein called PD-L1 (a marker sometimes used to guide cancer treatment decisions). The reported data shows that, among participants with low PD-L1 levels, 22 people had a recorded response to the treatment combination, as assessed by an independent review panel. When looking at all 188 treated participants together, 37 people had a recorded response according to the same independent review, or 36 people when assessed by the treating doctors directly. In the low PD-L1 group, the doctors' assessment recorded 20 people with a response. The reported data also includes a measure called "duration of response" — meaning how long a response lasted in those who had one. For all treated participants, this was reported as 13.4 months by the independent review panel and 15.9 months by the treating doctors. For the low PD-L1 group specifically, the figures were 13.4 months (independent review) and 14.3 months (treating doctors). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Bladder Cancer Trial, Completed

NCT03785925
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to give written consent to take part and follow the study's procedures
  • Your general health and ability to carry out daily activities meets a certain level (your doctor can assess this)
  • Your cancer can be measured on scans according to standard guidelines
  • You have been diagnosed with bladder or urinary tract cancer (urothelial/transitional cell carcinoma) that cannot be removed by surgery, has spread locally, or has spread to other parts of the body
  • You can provide either a recent tissue sample (biopsy) or stored tissue from a previous biopsy
  • You have not previously received chemotherapy or experimental treatments for your advanced or spread cancer
  • You are not able to receive a chemotherapy drug called cisplatin

Who may not be able to join:

  • You have an active autoimmune disease, or one that is known or suspected (a condition where the immune system attacks the body)
  • You have previously been treated with a therapy called IL-2
  • You have previously received certain immunotherapy drugs that target the immune system, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments, or other similar immune-based therapies
  • You have high blood pressure that has not been controlled on a stable treatment plan for at least 14 days before starting the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Nektar Therapeutics

Australian sites

St Vincent's Hospital Sydney, Darlinghurst, New South Wales
Tasman Health Care, Southport, Queensland
Adelaide Cancer Centre, Kurralta Park, South Australia
Monash Health, Monash Medical Centre, Bentleigh East, Victoria
St John of God Murdoch Hospital, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Nektar Therapeutics
Registry
ClinicalTrials.gov
Start date
29 April 2019
Est. completion
9 February 2022

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇹 Portugal 🇷🇺 Russia 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov