Phase 2 Mesothelioma Trial, Recruiting NCT06638931 Sponsor: Instituto do Cancer do Estado de São Paulo Condition: Mesothelioma
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Phase 2 Mesothelioma Trial, Recruiting

NCT06638931
Recruiting Phase 2

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 18 years of age or older.
  • Your tumor tissue test (a lab test called immunohistochemistry) shows a PD-L1 "combined positive score" (CPS) of 10 or higher (confirm with trial site).
  • Your cancer has gotten worse or you could not tolerate the standard treatments that are currently available for your cancer type.
  • Imaging scans (such as CT or MRI) have confirmed your cancer has grown or spread after your last treatment.
  • You are in good enough general health to carry out light daily activities, with no or minimal limitations (this is measured by a standard scale called ECOG, scored 0 or 1).
  • Your cancer has at least one area that can be measured on a scan, following standard measurement guidelines (called RECIST v1.1).
  • If you are male, you must either be infertile, have no partner who can become pregnant, or you and your partner agree to use contraception during the study and for at least 6 months after the last dose of the study drug; you must also agree not to donate sperm during this time.
  • If you are female, you must either be infertile or agree to use contraception throughout the study and for at least 6 months after the last dose of the study drug.
  • Your doctor estimates you are likely to live for more than 12 weeks.
  • Your blood tests show that your bone marrow, liver, and kidneys are working well enough to meet specific minimum levels set by the trial (confirm exact values with trial site).
  • You have been diagnosed with one of the specific rare cancers on the trial's approved list (such as cholangiocarcinoma, mesothelioma, soft tissue sarcoma, and many others), confirmed by a tissue biopsy; other rare cancers affecting fewer than 6 in every 100,000 people may also be considered with special approval (confirm with trial site).

Who may not be able to join:

  • You have previously been treated with immunotherapy drugs known as immune checkpoint inhibitors.
  • You are currently pregnant or breastfeeding.
  • You have another serious health condition that, in your doctor's opinion, would make participation unsafe.
  • You currently have an active infection.
  • You have had a major surgical procedure within the last 4 weeks.
  • You have moderate or severe heart failure (confirm with trial site).
  • You have had a heart attack or stroke within the last 6 months.
  • You have a history of scarring of the lungs (pulmonary fibrosis) or lung inflammation (pneumonitis).
  • You have an autoimmune disease, unless it is only vitiligo (a skin pigmentation condition) or a thyroid condition that is well controlled without immune-suppressing medications.
  • You have been diagnosed with a second, separate cancer in the last 3 years or have another cancer that is currently active, unless it is a non-melanoma skin cancer that has already been fully treated.
  • You have an abnormally prolonged electrical signal in your heart, known as a prolonged QT interval, detected on a heart tracing (ECG).
  • You have brain or spinal cord metastases that are not stable or controlled; previously treated brain metastases may be allowed if they have been stable on scans for at least 2 weeks and you are not taking steroids to manage them (confirm with trial site).
  • Cancer has spread to the membranes surrounding your brain or spinal cord (meningeal carcinomatosis).
  • Your kidney or liver function has been getting worse in the 14 days before enrolling.
  • You have had a solid organ transplant (such as a kidney, liver, or heart transplant) at any point.
  • You have an untreated immune deficiency condition; HIV-positive patients may be considered if their viral load is undetectable and they have no active infections or opportunistic diseases (confirm with trial site).
  • You regularly take steroid medications (such as prednisone) at a dose higher than 10 mg per day, unless it is for a non-autoimmune adrenal condition and your health is well managed at or below that dose.

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

Principal Investigator: Camila MV Moniz, Doctor, Oncologist

Phone: + 55 11 3893-3925

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
Recruiting
Phase
Phase 2
Sponsor
Instituto do Cancer do Estado de São Paulo
Registry
ClinicalTrials.gov
Start date
16 July 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

Primary Objective; Primary Endpoint

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