Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma (NCT05036434) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma
South Korea30 participantsStarted 2021-11-15
Plain-language summary
* Clinical Indication : Advanced adrenal cortical carcinoma after platinum-based chemotherapy
* Trial Type : Single arm, prospective trial
* Route of administration : Intravenous (pembrolizumab) and peroral (lenvatinib)
* Treatment Groups : Single arm
* Number of trial participants : 30
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of adrenal cortical carcinoma will be enrolled in this study.
✓. Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
✓. Patients who have received prior systemic therapy including combined mitotane and cisplatin-based chemotherapy as a palliative aim systemic therapy in advanced setting, and have had disease progression within 6 months of the last dose of the most recent systemic therapy. Patients who discontinued prior therapy due to intolerable toxicities can be included.
✓. Patients should have measurable disease according to RECIST v1.1 meeting the following criteria:
✓. at least 1 lesion of ≥10 mm in the longest diameter for a non-lymph node or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable according to RECIST using CT or MRI
✓. lesions that have had external beam radiotherapy or other loco-regoinal therapies such as radiofrequency ablastion must show subsequent evidence of substantial size increase to be deemed a target lesion.
✓. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
✓. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 mmHg at screening and no change in hypertensive medications within 1 week prior to the cycle 1 day 1.
Exclusion criteria
What they're measuring
1
To assess the antitumor activity of pembrolizumab plus lenvatinib in patients with advanced ACC.
Timeframe: Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Imaging assessment by RECIST v1.1.
. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
✕. Has received prior therapy with any VEGFR TKI or monoclonal antibody targeting VEGF pathway.
✕. Has received major surgery within 2 weeks of start of study intervention. Participants must have recovered from any toxicity and/or complications from major surgery prior to starting therapy.
✕. Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted unless the lesion is the only measurable lesion.
✕. Subjects having \>1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥1g/24-hour will be ineligible.
✕. Gastrointestinal malabsorption, gastrointestinal obstruction, or any other condition that might affect the absorption of lenvatinib.
✕. Significant cardiovascular impairment within 6 months of the first dose of study drug. History of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke, cardiac arrhythmia associated with significant cardiovascular impairment, or a left ventricular ejection fracture (LVEF) below the institutional normal range as determined by MUGA or echocardiogram.