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Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

ConditionsRecurrent Vulvar CancerPersistent Vulvar CancerMetastatic Vulva CancerLocally Advanced Vulvar Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAGO Research GmbH

About this trial

Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.

Female patients who are at least 18 years of age on the day signing informed consent

Histologically confirmed locally advanced, recurrent, persistent and/or metastatic VSCC not amenable for salvage surgery or definitive (chemo)radiation (additive palliative radiotherapy for symptom control is allowed)

≤2 previous lines of chemotherapy for recurrent or metastatic disease

Disqualifiers

Non squamous cell histology

Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula

Radiographic evidence of major blood vessel infiltration

Bradyarrhythmia

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

    400 mg Q6W

  • Lenvatinib

    Drug

    20 mg QD

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Treatment allocationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR within 24 weeks

ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Time frame
24 weeks

Secondary outcomes

1

Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall ORR

Overall ORR

Time frame
From date of starting study treatment until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months
2

Evaluate the efficacy of lenvatinib + pembrolizumab in terms of disease control rate (DCR)

DCR will be defined as the proportion of patients with PR, CR or stable disease (SD)

Time frame
For 8 weeks
3

Evaluate the efficacy of lenvatinib + pembrolizumab in terms of duration of response (DOR)

DOR will be defined as time from response until first progression or death, whichever occurs first

Time frame
Time from response until first progression or death, whichever occurs first, assessed up to 40 months
4

Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall survival (OS)

OS will be defined as the time from date of starting study treatment to death.

Time frame
Time from date of starting study treatment to death, assessed up to 40 months

Other outcomes

Sponsors and contacts

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

AGO Research GmbH

Lead sponsor

Source ClinicalTrials.gov
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