Single cEll pRofiling PErsistaNce To ImmuNothErapy

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT06680739
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg IV every 4 weeks
  • Tremelimumab — DRUG
    Tremelimumab 300 mg IV as a single dose

Study Details

The SERPENTINE trial (ESR 21-21165) is a phase II clinical study aiming to evaluate the efficacy of durvalumab and tremelimumab, alone or in combination, in patients with colorectal or endometrial cancer. The trial targets patients with microsatellite instability-high (MSI-H) tumors and those with microsatellite stable (MSS) tumors. Colorectal and endometrial cancers present significant challenges due to their heterogeneity and variable responses to treatment. Immunotherapy, particularly checkpoint inhibitors like durvalumab and tremelimumab, has shown promise in some patients, but predicting response remains elusive. The SERPENTINE trial aims to address this gap by investigating the effectiveness of these immunotherapies in a carefully selected patient population.

Key Dates

Start date
Mar 1, 2022
Status verified
May 2026
Primary completion
Jul 1, 2032
Completion
Jul 1, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control arm
    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.
  • Experimental: MSI arm
    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.
  • Experimental: MSS arm
    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.

Primary Outcome Measure

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

Central Contacts

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