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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

NCT06097728

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Unresectable Pleural Mesothelioma

Interventions: Volrustomig, Pemetrexed, Carboplatin, Cisplatin, Nivolumab

Countries: United States, Australia, Belgium, Brazil, Canada, China, Denmark, France

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Participant must be ≥ 18 years at the time of screening
* Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)
* Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy)
* WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing
* Has measurable disease per modified RECIST1.1
* Has adequate bone marrow reserve and organ function at baseline

Key Exclusion Criteria:

* As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
* Active or prior documented autoimmune or inflammatory disorders
* History of another primary malignancy with exceptions.
* Uncontrolled intercurrent illness
* Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment
* Untreated or progressive CNS metastatic disease
Locations (151)
  • Santa Rosa, California, United States
  • Aurora, Colorado, United States
  • Jacksonville, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Commack, New York, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Chermside, Australia
  • Clayton, Australia
  • Melbourne, Australia
  • Nedlands, Australia
  • Westmead, Australia
  • Anderlecht, Belgium
  • Antwerp, Belgium
  • Ghent, Belgium
  • Hasselt, Belgium
  • Sint-Niklaas, Belgium
  • Barretos, Brazil
  • Fortaleza, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Santo André, Brazil
  • São Paulo, Brazil
  • + 121 more on CT.gov