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SERPENTINENCT06680739

Single cEll pRofiling PErsistaNce To ImmuNothErapy

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date: Mar 1, 2022 to Dec 9, 2022 Show 5 more changesShow less
    • Eligibility criteria expanded, about 82 words
    • Enrollment closed, study ongoing
    • Final enrollment: 35 participants (planned 60)
    • Secondary endpoints: details revised at 7 of 9 entries
    • Site details revised
  2. Primary and study completion dates pushed to Jul 1, 2032v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Evaluation of Objective Response Rate (ORR)
Timeframe: From treatment initiation until objective response confirmation or progression of disease (24 months).

Secondary (9)

Antitumor Activity Assessment (PFS)
Antitumor Activity Assessment (OS)
Antitumor Activity Assessment (DoR)
Antitumor Activity Assessment (TTMR)
Antitumor Activity Assessment (irRR)
Show 4 moreShow less
Antitumor Activity Assessment (biomarkers)
Single-Cell Characterization of Persistent Cells
Correlation of Antitumor Activity with Biomarkers
Exploration of Immunotoxicity Biomarkers

Arms and interventions

Control armExperimental

Patients in this arm receive Durvalumab alone. Durvalumab is administered intravenously (IV) at a dose of 1500 mg every 4 weeks. This arm is designed to evaluate the efficacy and safety of Durvalumab monotherapy in patients with colorectal or endometrial cancer.

MSI armExperimental

Patients in this arm receive a combination of Durvalumab and Tremelimumab. They initially receive Tremelimumab as a single dose of 300 mg IV, followed by Durvalumab administered at a dose of 1500 mg IV every 4 weeks. This arm aims to assess the efficacy and safety of combining Durvalumab with Tremelimumab in patients with colorectal or endometrial cancer.

MSS armExperimental

Patients in this arm also receive a combination of Durvalumab and Tremelimumab. Similar to Cohorte 1B, they receive Tremelimumab as a single dose of 300 mg IV, followed by Durvalumab administered at a dose of 1500 mg IV every 4 weeks. However, patients in this arm have tumors with microsatellite stability (MSS), unlike Cohorte 1B where patients have tumors with microsatellite instability (MSI). This arm aims to evaluate the efficacy and safety of the Durvalumab and Tremelimumab combination in patients with MSS tumors.

Drugs: Durvalumab, Tremelimumab

Sites

1 site in 1 country

  • Vall d'Hebron Institute of OncologyBarcelona, Spain