Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers
- Conditions
- Salivary Gland CancerAdenoid Cystic Carcinoma
- Registration Number
- NCT04209660
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria:<br><br> - ACC Cohort (Cohort 1) only: Patients must have pathologically or cytologically<br> confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary<br> sites are allowed.<br><br> - Non-ACC Cohort (Cohort 2) only: Patients must have pathologically or cytologically<br> confirmed salivary gland cancer of any histology (except for adenoid cystic<br> carcinoma that is enrolled into cohort 1).<br><br> - Patients must have recurrent and/or metastatic disease not amenable to other<br> curative intent therapy.<br><br> - At least 4 weeks must have elapsed since the end of prior systemic treatment and/or<br> since completion of radiotherapy with resolution of all treatment related toxicity<br> to NCI CTCAE Version 5.0 grade =1 (or tolerable grade 2) or back to baseline (except<br> for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug<br> treatment.<br><br> - Patients must have RECIST V1.1 measurable disease defined as at least one non-nodal<br> lesion measuring = 20 mm with conventional techniques or as =10mm with CT scan, MRI,<br> or calipers by clinical exam in the longest dimension AND/OR a nodal lesion<br> measuring > 15 mm in the shortest dimension. Tumors in previously irradiated fields<br> may be considered measurable if there is evidence of tumor progression after<br> radiation treatment.<br><br> - Cohort 1 and acinic cell carcinoma patients in Cohort 2 only: Patients must have<br> documentation of a new or progressive lesion on radiologic imaging study performed<br> within 6 months prior to study enrollment (progression of disease over any interval<br> is allowed) and/or new/worsening disease related symptoms within 6 months prior to<br> study enrollment. Note: This assessment will be performed by the treating<br> investigator and evidence of progression by RECIST criteria is not required.<br><br> - Age = 18 years of age on the day of signing informed consent.<br><br> - ECOG performance status 0 or 1 (or Karnofsky = 70%).<br><br> - Patients must have tissue from the primary tumor or metastases available for<br> correlative studies. Either a paraffin block or at least 20 unstained slides are<br> acceptable (paraffin block or at 30 unstained slides would be ideal). Patients<br> without available tissue for submission may still be eligible if approved by the<br> Principal Investigator.<br><br> - Screening laboratory values must meet the following criteria:<br><br> - Neutrophils =1500/µL<br><br> - Platelets = 100x10^3/µL<br><br> - Hemoglobin = 9.0 g/dL (without packed red blood cell (pRBC) transfusion within<br> the last 2 weeks)<br><br> - AST and ALT = 2.5 x ULN (if liver metastases are present, AST and ALT = 5x ULN)<br><br> - Total Bilirubin = 1.5 x ULN OR direct bilirubin =ULN for participants with<br> total bilirubin levels >1.5 x ULN (except participants with Gilbert Syndrome,<br> who can have a total bilirubin < 3.0 mg/dL)<br><br> - Serum creatinine = 1.5 x ULN OR creatinine clearance (CrCl) = 40 mL/min per the<br> Cockcroft-Gault formula if creatinine is >1.5 x ULN<br><br> - Female CrCl = (140 - age in years) x weight in kg x 0.85 72 serum creatinine in<br> mg/dL<br><br> - Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in<br> mg/dL<br><br> - INR </= 1.5, unless participant is receiving anticoagulant therapy as long as<br> PT or aPTT is within therapeutic range of intended use of anticoagulants<br><br> - Participants must be willing to sign the written informed consent form. A signed<br> informed consent form must be appropriately obtained prior to the conduct of any<br> trial specific procedure.<br><br> - Male participants must agree to use adequate contraception as detailed in Appendix 2<br> of this protocol not be planning/expecting to father children, and refrain from<br> donating sperm from the time of the screening visit through 120 days after the last<br> dose of trial treatment.<br><br> - A female participant is eligible to participate if she is not pregnant (for women of<br> child-bearing potential, a pregnancy test must be negative within 24 hours prior to<br> initiation; if a urine test is positive or cannot be confirmed as negative, a serum<br> pregnancy test will be required), not breast feeding, not planning/expecting to<br> conceive children from the time of the screening visit through 120 days after the<br> last dose of trial treatment, and at least one of the following conditions applies:<br><br> - Not a woman of child bearing potential including:<br><br> - pre-menopausal with one of the following: documented hysterectomy, documented<br> bilateral salpingectomy, documented bilateral oophorectomy<br><br> - Postmenopausal females defined as no menses for 12 months without an<br> alternative medical cause (a high follicle stimulating hormone level in the<br> postmenopausal range may be used to confirm a post-menopausal state in women<br> not using hormonal contraception or hormonal replacement therapy (HRT).<br> However, in the absence of 12 months of amenorrhea, confirmation with two FSH<br> measurements in the postmenopausal range is required.<br><br> - A woman of child bearing potential who agrees to highly effective contraception<br> from the start of therapy through 120 days after the last dose of study<br> medication<br><br> - Participants must be able to swallow and retain oral medication or have a<br> functioning G-tube in place.<br><br>Exclusion Criteria:<br><br> - Untreated metastatic brain (subjects with treated brain metastases will be eligible,<br> provided that they are radiographically stable, i.e. without evidence of progression<br> for at least 4 weeks by repeat imaging (note that the repeat imaging should be<br> performed during study screening), clinically stable and without requirement of<br> steroid treatment for at least 14 days prior to the first dose of study treatment).<br><br> - Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery,<br> immunotherapy, biologic therapy or tumor embolization) other than study treatment.<br> Concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed,<br> provided they are started prior to study entry. Palliative radiation to non-target<br> lesions is also allowed.<br><br> - Prior malignancy if diagnosed and treated within 2 years of trial drug initiation<br> (with the exception of non-melanomatous skin cancers). Patients may be included if<br> they have completed therapy for a prior malignancy >2 years prior to drug initiation<br> and are currently NED. Participants with basal cell carcinoma of the skin, squamous<br> cell carcinoma of the skin, or carcinoma in situ (breast DCIS, or cervical CIS) that<br> have undergone potentially curative at any time therapy are not excluded from trial<br> participation.<br><br> - History of allergy or intolerance to study drug components (or any of their<br> excipients), or severe (> Grade 3) hypersensitivity reaction to any excipients of<br> pembrolizumab or any monoclonal antibody.<br><br> - Prior use of lenvatinib or any PD-1/PD-L1 or anti-PD-L2 targeted therapies or with<br> an agent directed at another stimulatory or co-inhibitory T-cell receptor (CTLA-4,<br> OX-40, CD137).<br><br> - Uncontrolled hypertension (systolic pressure >140mm Hg or diastolic pressure >90mm<br> Hg),
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method best overall response rate
- Secondary Outcome Measures
Name Time Method median progression-free survival (PFS)