Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis
Conditions
Keywords
Folate Receptor Alpha, Antibody-drug Conjugate, Platinum-Resistant, Platinum-Sensitive
Brief summary
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Interventions
DRUGSofetabart Mipitecan
Administered IV
DRUGPaclitaxel
Administered IV
DRUGTopotecan
Administered IV
DRUGGemcitabine
Administered IV
DRUGPegylated liposomal doxorubicin (PLD)
Administered IV
DRUGMIRV
Administered IV
DRUGBevacizumab
Administered IV
DRUGCarboplatin
Administered IV
Sponsors
Eli Lilly and Company
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part A and B: * Have histologically confirmed high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer. * Have confirmed availability of tumor tissue block or slides * Have radiographic progression on or after most recent line of systemic anticancer therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Have measurable disease per RECIST v1.1 Part A: * Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy. * Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine. * Have received prior bevacizumab treatment, unless documented contraindication or intolerance. * Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance. Part B: * Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy * Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy * Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.
Exclusion criteria
Part A and B: \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: \- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy. Part B: \- Have clinically significant proteinuria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Randomization to radiographic progression or death from any cause (up to 70 months) | PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Randomization to date of death from any cause (up to 70 months) | — |
| PFS | Randomization to radiographic progression or death from any cause (up to 70 months) | PFS by blinded independent central review (BICR) |
| Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) | Randomization to disease progression or death (up to 70 months) | ORR per RECIST v1.1 |
| Duration of Response (DOR) | Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months) | DOR per RECIST v1.1 |
| Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) | Randomization to disease progression or death from any cause (up to 70 months) | DCR per RECIST v1.1 |
| PFS2 | Randomization to disease progression on next line of treatment or death from any cause (up to 70 months) | — |
| Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD) | Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months) | — |
| Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG) | Randomization to 30 days post treatment discontinuation | Per GCIG |
| Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5) | Randomization to 30 days post treatment discontinuation | FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. High side effect bother is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden. |
| Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28) | Randomization to 30 days post treatment discontinuation | The EORTC OV28 consists of 28 items covering 3 functional scales and 5 symptom scales. The Abdominal/GI symptom scale ranges from 0 to 100. Higher scores indicate worse symptoms. |
| Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale | Randomization to 30 days post treatment discontinuation | The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 0 - 100. Higher score represents better overall HRQoL. |
| Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156 | Randomization through end of treatment (up to 70 months)] | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed