Single cEll pRofiling PErsistaNce To ImmuNothErapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVall d'Hebron Institute of Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age > 18 years at time of study entry.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Cohort 1: histologically confirmed recurrent or metastatic CRC or endometrial cancer irrespective of prior treatment history with chemotherapy and/or targeted agents, not amenable to surgery and known tumor MSI-H or dMMR status per local standard of practice.
Disqualifiers
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
Trial design
Design model
Parallel
Treatments tested in this trial
Durvalumab
DrugDurvalumab 1500 mg IV every 4 weeks
Tremelimumab
DrugTremelimumab 300 mg IV as a single dose
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Control armExperimental treatment 1 intervention
Group B: MSI armExperimental treatment 2 interventions
Group C: MSS armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Evaluation of Objective Response Rate (ORR)
Assess the objective response rate (ORR) of Durvalumab or Tremelimumab 300 mg single dose followed by Durvalumab in patients with microsatellite instable (MSI) colorectal cancer (CRC) or endometrial cancer (EC) and Tremelimumab 300 mg single dose followed by Durvalumab in refractory microsatellite stable (MSS) CRC and EC according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame
From treatment initiation until objective response confirmation or progression of disease (24 months).Secondary outcomes
1
Antitumor Activity Assessment (PFS)
Evaluate the antitumor activity of Durvalumab + Tremelimumab in MSS CRC/EC and MSI CRC/EC based on progression-free survival (PFS).
Time frame
Throughout the study duration (24 months).2
Antitumor Activity Assessment (OS)
Evaluate the antitumor activity of Durvalumab + Tremelimumab in MSS CRC/EC and MSI CRC/EC based on overall survival (OS).
Time frame
Throughout the study duration (24 months).3
Antitumor Activity Assessment (DoR)
Evaluate the antitumor activity of Durvalumab + Tremelimumab in MSS CRC/EC and MSI CRC/EC based on duration of response (DoR).
Time frame
Throughout the study duration (24 months).4
Antitumor Activity Assessment (TTMR)
Evaluate the antitumor activity of Durvalumab + Tremelimumab in MSS CRC/EC and MSI CRC/EC based on time to maximum response (TTMR).
Time frame
Throughout the study duration (24 months).Sponsors and contacts
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Source ClinicalTrials.gov