KCT0006789
Recruiting
未知
A Prospective Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma After Failure of Platinum- and Mitotane-Based Chemotherapy (ACCOMPLISH)
ational Cancer Center0 sites30 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- ational Cancer Center
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.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.
- •2\.Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- •3\.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.
- •4\.Patients who have refused cytotoxic chemotherapy can be included.
- •5\.Patients should have measurable disease according to RECIST v1\.1 meeting the following criteria:
- •a. 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
- •b. 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.
- •6\.Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
- •7\.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\.
- •8\.Adequate renal function defined as creatinine \=1\.5 times the upper limit of normal (×ULN) or calculated creatinine clearance \=30 ml/min per the Cockcroft and Gault formula
Exclusion Criteria
- •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\).
- •2\.Has received prior therapy with any VEGFR TKI or monoclonal antibody targeting VEGF pathway.
- •3\.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.
- •4\.Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted unless the lesion is the only measurable lesion.
- •5\.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.
- •6\.Gastrointestinal malabsorption, gastrointestinal obstruction, or any other condition that might affect the absorption of lenvatinib.
- •7\.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.
- •8\.Prolongation of QTc interval to \>480 msec
- •9\.Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
- •10\.Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Outcomes
Primary Outcomes
Not specified
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