Phase 2 Mesothelioma Trial, Terminated NCT04914897 Sponsor: Sanofi Condition: Mesothelioma
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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 106 people across four groups. All participants had either non-small cell lung cancer (NSCLC) or mesothelioma (a cancer affecting the lining of the lungs or other organs), and all received a combination of two medicines — pegenzileukin and pembrolizumab. The trial was measuring how many participants' tumours shrank or disappeared (called the "objective response rate"), as well as tracking side effects and how quickly any response appeared. The reported data shows that in the lung cancer group whose tumours had the highest levels of a particular protein marker (PD-L1 ≥50%, 17 people), 41.2% had their tumours shrink or disappear by the required amount. In the lung cancer group with moderate protein marker levels (PD-L1 1–49%, 20 people), that figure was 15.0%. For the group who had already received earlier treatments for lung cancer (40 people), only 2.5% showed that level of tumour shrinkage, and in the mesothelioma group (29 people) who had also received prior treatments, the figure was 3.4%. The reported data also shows that all participants in every group experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred during treatment), and serious adverse events were recorded in 6, 11, 21, and 13 participants across the four groups respectively. One participant in the previously-treated lung cancer group experienced what the trial defined as a dose-limiting toxicity (a side effect serious enough to potentially limit the dose used). The time from starting treatment to first recorded tumour response ranged from approximately 2.2 to 4.1 months across the groups. 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 Mesothelioma Trial, Terminated

NCT04914897
Terminated 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 must be 18 years of age or older (or the legal adult age in your country) at the time of signing the consent form
  • You have been diagnosed with Stage IV non-small cell lung cancer (advanced lung cancer that has spread), confirmed by a tissue or cell sample — this applies to certain groups in the trial
  • You have been diagnosed with a type of cancer affecting the lining of the lung (malignant pleural mesothelioma) that cannot be removed by surgery — this applies to one specific group in the trial
  • Depending on which group you may join, your tumor must show certain levels of a protein called PD-L1 (a lab result your doctor can check)
  • Depending on which group you may join, you may need to have had specific prior cancer treatments, or in some groups, no prior treatment for advanced disease
  • Your cancer must be measurable on scans
  • Some participants in certain groups may need to agree to a tissue sample (biopsy) at the start of the trial
  • For one group, your doctor must judge that certain standard chemotherapy drugs are not the best option for you
  • Women must not be pregnant or breastfeeding, and if there is any chance you could become pregnant, you must agree to use approved contraception and avoid donating or freezing eggs for 150 days after finishing the study treatment
  • Men must agree to use approved contraception or abstain from sex with women who could become pregnant, and avoid donating or freezing sperm, for at least 210 days after finishing the study treatment
  • You must be able to understand and sign a consent form agreeing to take part

Who may not be able to join:

  • Your general health and ability to carry out daily activities is significantly limited (confirm with trial site)
  • Your blood counts or organ function (such as liver or kidneys) are too low (confirm with trial site)
  • Your blood oxygen level is too low (92% or below when measured with a pulse oximeter)
  • You have active cancer that has spread to the brain or the lining around the brain or spinal cord
  • You have previously had an organ or tissue transplant from another person
  • You have received cancer treatment or any experimental treatment within the past 28 days, or major surgery within the past 28 days
  • You have previously been treated with a specific type of cancer drug called IL-2
  • You have a condition that currently requires you to take steroid (corticosteroid) medication
  • You have taken antibiotics (other than creams or ointments applied to the skin) within the 14 days before starting the trial
  • You have had a serious or unstable heart condition within the past 6 months
  • You have an active autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the past 2 years
  • You have another cancer that is growing or being actively treated within the last 3 years
  • For certain groups in the trial: you have previously been treated with drugs that target the PD-1/PD-L1 pathway (a type of immunotherapy), unless you have written proof you were in a control group that did not receive this treatment
  • You have received a live-virus vaccine within the 28 days before starting treatment (standard flu vaccines without live virus are allowed)

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 28 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

Australian sites

Investigational Site Number : 0360002, Richmond, Victoria

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
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
23 September 2021
Est. completion
18 July 2023

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇱 Chile 🇫🇷 France 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Cohorts A1 and A2: Objective Response Rate (ORR); Cohorts B1: Objective Response Rate; Cohorts C1: Objective Response Rate

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: 28 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