Health Trials

A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

ConditionsOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have histologically confirmed high-grade serous or 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.

Disqualifiers

Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sofetabart Mipitecan

    Drug

    Administered IV

  • Paclitaxel

    Drug

    Administered IV

  • Topotecan

    Drug

    Administered IV

  • Gemcitabine

    Drug

    Administered IV

  • Pegylated liposomal doxorubicin (PLD)

    Drug

    Administered IV

  • MIRV

    Drug

    Administered IV

  • Bevacizumab

    Drug

    Administered IV

  • Carboplatin

    Drug

    Administered IV

Treatment groups

1,630 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: Sofetabart MipitecanExperimental treatment 1 intervention
Group B: Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)Active comparator 5 interventions
Group C: Part B: Sofetabart Mipitecan plus BevacizumabExperimental treatment 2 interventions
Group D: Part B: Platinum-based Doublet Chemotherapy plus BevacizumabActive comparator 5 interventions
Group E: Part C: Sofetabart Mipitecan plus BevacizumabExperimental treatment 2 interventions
Group F: Part C: Platinum-based Doublet Chemotherapy plus BevacizumabActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

Time frame
Randomization to radiographic progression or death from any cause (up to 70 months)
2

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)

Time frame
Randomization to radiographic progression or death from any cause (up to 70 months)

Secondary outcomes

1

Overall Survival (OS)

Time frame
Randomization to date of death from any cause (up to 70 months)
2

PFS

PFS by blinded independent central review (BICR)

Time frame
Randomization to radiographic progression or death from any cause (up to 70 months)
3

Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)

ORR per RECIST v1.1

Time frame
Randomization to disease progression or death (up to 70 months)
4

Duration of Response (DOR)

DOR per RECIST v1.1

Time frame
Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

GOG Foundation

Collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Asia-Pacific Gynecologic Oncology Trials Group

Collaborator

Source ClinicalTrials.gov
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