2024-515646-16-00
Recruiting
Phase 2
Pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulvar cancer not amenable to curative surgery or radiotherapy
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- AGO Research GmbH
- Enrollment
- 42
- Locations
- 15
- Primary Endpoint
- Efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR). 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)
Overview
Brief Summary
To evaluate the efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR).
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Measurable disease (investigator assessed RECIST 1.1). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Eastern cooperative oncology group (ECOG) performance status of 0-
- •Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- •No pregnancy (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]), no breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) as defined in APPENDIX 3 OR b.) A WOCBP who agrees to follow the contraception and pregnancy testing recommendations for investigational medicinal products (IMPs) with demonstrated or suspected human teratogenicity/ fetotoxicity in early pregnancy of the CTFG-guideline in APPENDIX 3 during the treatment period and for at least 6 months after the last dose of study treatment. In addition to the described highly effective oral/transdermal contraception methods a barrier method must be used. A WOCBP should not become pregnant during the treatment and for at least 6 months after the last dose of study treatment.
- •Available archival tumor tissue sample and/or newly obtained core or excisional biopsy of a tumor lesion ideally not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides
- •Adequate organ function as defined in Table
Exclusion Criteria
- •Non squamous cell histology
- •Diagnosis of immunodeficiency
- •Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- •History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years (time requirement does not apply for definitively treated early endometrial cancer (FIGO IA/B), in-situ carcinomas [e.g. breast, cervix, bladder], or basal or squamous cell carcinoma of the skin).
- •Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
- •Active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
- •History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Active infection requiring systematic therapy.
- •Has active hemoptysis within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior randomization
- •Known history of Human Immunodeficiency Virus (HIV) infection
Outcomes
Primary Outcomes
Efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR). 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)
Efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR). 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)
Secondary Outcomes
- ORR for whole trial duration. DCR=proportion of pts with PR/CR/SD for 8 weeks. DOR=time from response until 1st PD or death, whichever occurs first. OS=time from therapy start to death. PFS=time from therapy start to PD or death, whichever occurs first. TFST=time from therapy start until start of 1st subsequent therapy or death whichever occurs first. TSST=time from therapy start until start of 2nd subsequent therapy or death whichever occurs first. Tumor response assessed by INV per RECIST 1.1.
- Quality of life is measured by patient reported outcome instruments EORTC QLQ-C30 and QLQ-VU34.
- Events according to common terminology criteria for adverse events (CTCAE Version 5.0), dose reductions, delays or interruptions.
Investigators
Study Office
Scientific
AGO Research GmbH
Study Sites (15)
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