Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) monotherapy and in combination in recurrent or Stage IVB cervical cancer

Korábbi kezelés

• 2- Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
• 3- Has Clinically significant bleeding issues or risks. Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) ( Arm A and bevacizumab-eligible participants in Arm H)
• 6- Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
• 8-Requires anti-coagulation therapy (Arms A and H only

Más betegség

• 4- Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arm A and Bev eligible Arm H only)
• 7-Clinically significant cardiac disease

Egyéb

• Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
• 5- Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arm A and Bev eligible Arm H only)

• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after SOC treatments or are ineligible or intolerant to SOC for recurrent or stage IVB cervical cancer. (Arms A, B, and C only).
• Criterion revised per Amendment 6&7. Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E and H).
• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than 2 prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and Arm G only).
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
• Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration. A WOCBP must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration (all arms).
• Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).