Safety and Efficacy of Tisotumab Vedotin in Combination With Other Cancer Agents in Subjects With Cervical Cancer



Status:Recruiting
Conditions:Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 30, 2018
End Date:April 2022
Contact:Genmab A/S Trial Information
Email:clinicaltrials@genmab.com
Phone:+4570202728

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A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer

This is an open label, multi-center trial of tisotumab vedotin in combination with
bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical
cancer.

The trial consists of two-parts a dose escalation part and an expansion part. The expansion
part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the
combinations have been determined in the dose escalation part.

The dose escalation part will occur in cervical cancer subjects who have progressed during or
after standard of care therapy and who are intolerant or ineligible to receive standard of
care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and
bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin
+ carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed
doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin.

The dose expansion part will consist of subjects with recurrent or stage IVB cervical cancer,
who have not received prior systemic therapy for their recurrent or stage IVB disease, Arms D
and E being treated with tisotumab vedotin + carboplatin or tisotumab vedotin +
pembrolizumab, respectively, or subjects, who have progressed on or after standard of care
treatments, Arm F treated with tisotumab vedotin + pembrolizumab. Subjects enrolled to these
arms will receive the RP2D of tisotumab vedotin established in the dose escalation part.

Inclusion Criteria:

- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on
or after standard of care treatments or are ineligible or intolerant to standard of
care for recurrent or stage IVB cervical cancer (Arms A, B and C only).

- 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 and
E only).

- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on
or after at least one but no more than two standard of care treatments for recurrent
or stage IVB cervical cancer (Arm F only).

- Must have baseline measurable disease per RECIST v1.1.

- Must be at least 18 years of age on the day of signing informed consent (All Arms).

- 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

- Women of childbearing potential must agree to use adequate contraception during and
for 6 months after the last dose of trial treatment administration.

- 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).

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)

- Has clinically significant bleeding issues or risks

- Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or
more) (Arm A only)

- Recent (within 4 weeks of first dose of trial treatment) clinically significant
gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arm A only)

- Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing
complications that require medical intervention (Arm A only)

- Has active ocular surface disease at baseline. Subjects with prior history of
cicatricial conjunctivitis are ineligible (All Arms).

- Clinically significant cardiac disease

- Requires anti-coagulation therapy
We found this trial at
1
site
90 Poly Drive
Billings, Montana 59102
Principal Investigator: Benjamin Marchello, MD
?
mi
from
Billings, MT
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