OncoMatch/Clinical Trials/NCT03675893
RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer
Is NCT03675893 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for endometrial cancer.
Treatment: Letrozole · Abemaciclib · LY3023414 · Metformin · Gedatolisib — This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer. The drugs involved in this study are: * Abemaciclib (also known as Verzenio™) * Letrozole (also known as Femara®) * Metformin (also known as Glucophage®) * Gedatolisib (also known as PF-05212384)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Endometrial Cancer
Biomarker criteria
Required: ESR1 expression (≥ 1 percent of tumor cell nuclei immunoreactive by ihc)
Required: TP53 wild-type
Required: TP53 wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: cdk4/6 inhibitor
Cannot have received: cdk4/6 inhibitor
Exception: for cohort 7, prior cdk4/6 inhibitor therapy is required
Cannot have received: metformin
Exception: if enrolling to cohort 3
Cannot have received: pi3k pathway inhibitor
Exception: for cohorts 6 and 7, up to 10 patients per cohort may have received prior mtor inhibitor therapy such as everolimus
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,500/mcl; platelets ≥ 100,000/mcl
Kidney function
creatinine ≤ 1.5 × institutional uln or creatinine clearance ≥ 60 ml/min/1.73 m2 for participants with creatinine levels above institutional normal
Liver function
total bilirubin ≤ 1.5 × institutional uln (gilbert's syndrome: ≤ 2.0 × uln and direct bilirubin within normal limits); ast(sgot)/alt(sgpt) ≤ 3× institutional uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03675893 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cdk4/6 inhibitor, metformin, pi3k pathway inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages