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OncoMatch/Clinical Trials/NCT06680739

Single cEll pRofiling PErsistaNce To ImmuNothErapy

Is NCT06680739 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Tremelimumab for colorectal cancer.

Phase 2RecruitingVall d'Hebron Institute of OncologyNCT06680739Data as of May 2026

Treatment: Durvalumab · TremelimumabThe 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Endometrial Cancer

Biomarker criteria

Allowed: EGFR positive

if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required

Allowed: KRAS wild-type

if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required

Allowed: NRAS wild-type

if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy with or without bevacizumab — advanced/metastatic CRC

progressed during or after, at least 2 lines of fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy with or without bevacizumab according to institutional practice or have not tolerated therapy for advanced/metastatic disease

Must have received: anti-EGFR therapy — advanced/metastatic CRC, EGFR positive/RAS wild type

if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required

Must have received: platinum and taxane-based regimen — advanced/metastatic endometrial cancer

progressed during or after a platinum and taxane-based regimen, not amenable to surgery

Cannot have received: anti-PD-1 therapy

Has previously received prior therapy with an anti-PD-1

Cannot have received: anti-PD-L1 therapy (durvalumab)

Has previously received prior therapy with ... anti-PD-L1 including durvalumab

Cannot have received: anti-CTLA-4 therapy (ipilimumab)

Has previously received prior therapy with ... anti CTLA-4 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Cannot have received: monoclonal antibody

Has had a prior anti-cancer mAb within 4 weeks prior to study Day 1

Cannot have received: chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy

Has had prior chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy for cancer therapy within 2 weeks prior to study Day 1

Lab requirements

Blood counts

Hemoglobin ≥9.0 g/dL; ANC ≥1500 per mm3; Platelet count ≥100 x 10^9/L (>75,000 per mm3)

Kidney function

Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by Cockcroft-Gault or 24-hour urine collection; Creatinine ≤1.5 x ULN OR measured/calculated creatinine clearance ≥60 mL/min for subjects with creatinine >1.5 x ULN

Liver function

Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5 x ULN

Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL; ANC ≥1500 per mm3; Platelet count ≥100 x 10^9/L (>75,000 per mm3); Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5 x ULN; Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by Cockcroft-Gault or 24-hour urine collection; Creatinine ≤1.5 x ULN OR measured/calculated creatinine clearance ≥60 mL/min for subjects with creatinine >1.5 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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