Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies
ConditionAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmaMar
About this trial
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 criteria
Qualifiers
Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures.
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.
Have a pathologically confirmed diagnosis of advanced malignancy.
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.
Disqualifiers
Prior treatment with PM54 or any other ecteinascidin agent, including ecubectedin, trabectedin, and lurbinectedin.
History of hypersensitivity to PM54, pembrolizumab, or any of the inactive ingredients.
History of other malignancies within 3 years prior to start of study intervention, except adequately resected non-melanoma skin cancer or other in-situ disease at neglectable risk of relapse.
Presence of carcinomatous meningitis.
Trial design
Treatments tested in this trial
- Pembrolizumab
- PM54
Treatment groups
119 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov