Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
ConditionRenal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male/female participants who are at least 18 years of age on the day of signing informed consent
Level 1 tumor thrombus is either at the entry of renal vein or within the IVC < 2 cm from the confluence of renal vein and IVC
Level II tumor thrombus extends within the IVC > 2 cm above the confluence of renal vein and IVC, but still remains below the hepatic veins.
Level III tumor Thrombus involves the intrahepatic IVC.
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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 systemic anti-cancer therapy including investigational agents prior to allocation.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Trial design
Design model
Single group
Treatments tested in this trial
Neoadjuvant Lenvatinib
Drug20 mg PO daily for 12 weeks prior to surgery
Neoadjuvant Pembrolizumab
Drug200 mg IV every 3 weeks for 4 doses prior to surgery
Radical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection
Procedure/SurgeryResection of locally advanced RCC with IVC tumor thrombus
Adjuvant Pembrolizumab
Drug200 mg IV every 3 weeks for up to 13 doses after surgery
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Disease Control Rate
Evaluation of changes in size of primary tumor and size and level of IVC tumor thrombus on imaging due to neoadjuvant therapy prior to surgery.
Time frame
12 weeks2
Local and Metastatic Progression Rate
Evaluation of local or metastatic progression on imaging prior to surgery following neoadjuvant therapy.
Time frame
12 weeks3
90 Day Post-Operative Complications
Assessment of 90 day post-operative safety and morbidity of neoadjuvant therapy by evaluating the incidence of 90 day post-operative grade 3-5 adverse events.
Time frame
13 weeksSecondary outcomes
1
Estimated blood loss
Estimated blood loss in mL during surgery
Time frame
1 week2
Operative time
Operative time in minutes of surgery, length of stay, and intra-operative and post-operative complications
Time frame
1 week3
Length of stay
Length of stay of hospital stay for surgery in days, and intra-operative and post-operative complications
Time frame
1 week4
Intra-operative complications
Complications that occur during surgery
Time frame
1 weekOther outcomes
1
Exploratory Outcomes
Identify metabolic signatures in plasma that are noninvasive predictors of therapy response and identify metabolic alterations following neoadjuvant therapy in patients who do and do not respond.
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov