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

Phase 1

• Conditions: recurrent or stage IVB cervical cancer; MedDRA version: 21.1Level: PTClassification code 10008342Term: Cervix carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004758-40-NL
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

- 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
Criterion revised per Amendment 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.
- 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

- Has clinically relevant bilateral hydronephrosis which cannot be
alleviated by ureteral stents or percutaneous drainage. (All Arms)
- 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)
- Criterion revised per Amendment 6
- Criterion revised per Amendment 7
- Has clinically significant bleeding issues or risks
- Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arms A and H)
- Recent (within 4 weeks of first dose of trial treatment) clinically
significant gastrointestinal or vaginal bleeding requiring PRBC
transfusion (Arm A and bevacizumab-eligible subjects in Arm H)
- Recent (within 4 weeks of first dose of trial treatment) evidence of
wound healing complications that require medical intervention (Arm A and bevacizumab-eligible subjects in Arm H)
Criterion revised per Amendment 6
- Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified