A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants Who Were Previously Treated for Advanced Malignancies

PharmaMar

Summary

The main purpose of the study is to evaluate the safety, tolerability and recommended dose of PM54 in combination with pembrolizumab. To assess the antitumor activity of PM54 in combination with pembrolizumab in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator's assessment in participants in other cohorts.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures. 2. Adults (greater than or equal to \[\>=\]18 years or legal consenting age, per local regulations), and able to provide free and informed consent for study participation. 3. Have a pathologically confirmed diagnosis of advanced malignancy. 4. Have advanced disease, as defined by progressive, relapsed, or metastatic disease that is not amenable to multimodal ablative or excisional treatments with curative intent, according to international guidelines. 5. Ha…

A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants Who Were Previously Treated for Advanced Malignancies

Summary

Eligibility

Interventions

Locations (11)