Clinical trial · Interventional
Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
Phase II Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following discussion with the Cancer Center the PI elected to terminate the study.
Summary
Brief summary (as posted)
To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic dMMR Solid Cancer | — | UNRESOLVED | — |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sirolimus 2mg Tablet | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sirolimus
- description
- Participants will be instructed to take 2 milligrams (mg) every day for 28 days (1 cycle). They will be evaluated in the oncology clinic every 2 weeks to make sure they are tolerating the medication well.
- interventionNames
- Drug: Sirolimus 2mg Tablet
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 24 weeks after achieving therapeutic sirolimus levels, up to 7 months total
- description
- To evaluate the efficacy of sirolimus in patients with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment), ORR will be determined. For this study ORR will be defined as the percentage of patients who achieve either a complete response (CR = disappearance of all target tumors); or a partial response (PR = ≥30% decrease in the sum of the longest diameters of target tumors) based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) following review of imaging (CT-CAP or PET-CT) data.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic solid cancer tumor after immunotherapy (either due to progression of disease or inability to tolerate treatment) * dMMR by immunohistochemistry (IHC) defined as the loss of expression in any of the four major MMR proteins (MLH1, MSH2, MSH6 and PMS2) or by next- generation sequencing (NGS) * Age older than 18 at the time of informed consent * Eastern Cooperative Oncology Group performance status of 0-2 * ≥1 measurable lesion based on RECIST, version 1.1 (16) * Absolute neutrophil count (ANC) ≥1,500 mm3 * Platelet count ≥75,000 mm3 * Hemoglobin ≥ 9 g/dl * Aspartate aminotransferase (AST) ≤3.0 times the upper normal limit (UNL) * Alanine aminotransferase (ALT) ≤3.0 times the upper normal limit (UNL) Bilirubin ≤1.5 times the UNL * Serum creatinine ≤1.5 times the UNL Exclusion Criteria: * Received immunotherapy in the prior 21 days. * Have not recovered from toxicities of prior treatments to at least grade 1. * Symptomatic central nervous system (CNS) metastases * Pregnancy or Breast-feeding.
References
Publications (0)
Data not yet available