Tests sacituzumab tirumotecan with pembrolizumab for metastatic cervical cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with cervical cancer that has come back, not gone away, or is newly found and has spread. The tumour must show PD-L1 CPS of 1 or more.

Age

18 years or older

Sex

Women only

Disease stage

Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix that is persistent, recurrent, or newly diagnosed and spread (FIGO-2018 Stage IVB), and cannot be treated with surgery or radiation meant to remove all of the disease. Performance status 0 or 1.

Earlier treatment

People who had other systemic cancer treatment not allowed by the protocol cannot join.

Biomarker or test result

Tumour PD-L1 expression with a combined positive score of 1 or more. If HIV-positive, HIV must be well controlled on antiretroviral therapy. If hepatitis B or C, viral load must be undetectable.

Main reasons for not taking part

• HIV with a history of Kaposi's sarcoma or Multicentric Castleman's Disease
• Severe dry eye, severe eyelid gland disease or severe corneal disease
• Inflammatory bowel disease, or a history of it
• Immunodeficiency, or active autoimmune disease treated in the past 2 years
• History of stem cell or solid organ transplant

The registry criteria, word for word

What the trial wants to find out

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.

The 3 groups in the trial

• Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + BevacizumabTreatment being tested

  Participants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 20 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

  Treatment: Pembrolizumab, Sacituzumab Tirumotecan, Bevacizumab, and Rescue Medications

• Part 2: Sac-TMT + Pembrolizumab +/- BevacizumabTreatment being tested

  During induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m\^2 q3w for up to 6 cycles, and cisplatin 50 mg/m\^2 q3w (or carboplatin area under the curve \[AUC\]5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long. During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

  Treatment: Pembrolizumab, Sacituzumab Tirumotecan, Bevacizumab, Paclitaxel, Cisplatin, Carboplatin, and Rescue Medications

• Part 2: Pembrolizumab +/- BevacizumabExisting treatment, for comparison

  During induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m\^2 q3w for up to 6 cycles, and cisplatin 50 mg/m\^2 q3w (or carboplatin AUC 5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long. During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

  Treatment: Pembrolizumab, Bevacizumab, Paclitaxel, Cisplatin, and Carboplatin