Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy

  • End date
    Apr 14, 2023
  • participants needed
  • sponsor
    Albert Einstein College of Medicine
Updated on 14 June 2022
platelet count
measurable disease
neutrophil count
primary cancer
solid tumour
solid neoplasm


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).


Despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dMMR) solid tumors remain scarce. Pre-clinical data suggests that dMMR tumors are susceptible to rapamycin (sirolimus), a mTOR inhibitor. In these tumors, characterized by higher levels of oxidative stress, sirolimus can exert a cytotoxic effect, led by the failure to repair DNA damage by inhibition of antioxidant enzymes such as FOXO3a triggered by Akt hyperactivation.

This proposal presents a phase 2 clinical trial designed to evaluate the efficacy of sirolimus in patients with dMMR solid tumors after immunotherapy. The investigators hypothesize that sirolimus will increase the overall response rate (ORR) by 20%.

Condition Metastatic dMMR Solid Cancer, Solid Tumor, Cancer, Metastatic Solid Tumor
Treatment Sirolimus 2Mg Tab
Clinical Study IdentifierNCT04393454
SponsorAlbert Einstein College of Medicine
Last Modified on14 June 2022


Yes No Not Sure

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
Clear my responses

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