Phase
Condition
Carcinoma
Urothelial Cancer
Urothelial Tract Cancer
Treatment
Sasanlimab
Palbocicilib
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Cytologically or histologically confirmed clear cell renal cell carcinoma (presenceof a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)
Participants must have advanced RCC with at least one measurable lesion as outlinedin RECIST 1.1.
Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapyand must have received or been ineligible to receive a VEGF pathway antagonist (as asingle agent or as part of a combination)
Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previouslyreceived systemic treatment for pRCC
Age >= 18 years
ECOG performance status <= 1
Adequate hematologic function at screening, as follows:
Absolute neutrophil count (ANC) >= 1,000/microliter
Hemoglobin (Hb) >= 9 g/dL with no blood transfusion within 2 weeks prior totreatment initiation
Platelets >= 100,000/microliter
Adequate renal and hepatic function at screening, as follows:
Serum creatinine <= 1.5 x upper limit of normal (ULN) OR, if >1.5x ULN,creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2 (calculated CrCl (CKD-EPI orcalculated eGFR provided by laboratory))
Total bilirubin <= 1.5 x ULN OR in participants with known or suspectedGilbert's syndrome, total bilirubin <= 3.0 x ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 xULN, (unless liver metastases are present, then values must be <= 5 x ULN)
Participants serologically positive for hepatitis C virus (HCV) are eligible if HCVviral load is undetectable
Participants serologically positive for human immunodeficiency virus (HIV) areeligible if they are on stable antiretroviral therapy for at least 4 weeks beforetreatment initiation, have no reported opportunistic infections or Castleman sdisease within 12 months prior to treatment initiation, have a viral load that isundetectable by quantitative polymerase chain reaction (PCR) and CD4 count >= 200cells per cubic millimeter
Participants with brain metastasis are eligible if at least 4 weeks status postradiotherapy or surgery before treatment initiation with no evidence of progressionor associated symptoms
Women of child-bearing potential (WOCBP) must agree to use one (1) highly effectivemethod of contraception (e.g.,hormonal, intrauterine device (IUD), surgicalsterilization) prior to study entry, for the duration of study therapy, and for upto 6 months following the last dose of any study agent(s). Women must refrain fromdonating eggs during this same period. NOTE: WOCBP is defined as any female who hasexperienced menarche and who has not undergone successful surgical sterilization orwho is not postmenopausal.
Men with female partners of reproductive potential and pregnant partners arerequired to use a condom (even after vasectomy), during treatment and for at least 6months after the final dose and must refrain from donating sperm during this sameperiod.
Breastfeeding participants must be willing to discontinue breastfeeding from studyenrollment through 6 months after study treatment discontinuation
Participants must be able to understand and be willing to sign a written informedconsent document
Exclusion
EXCLUSION CRITERIA:
Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy,treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5halflives, whichever is shorter, prior to treatment initiation
More than two prior lines of systemic therapy in the metastatic setting
Participants who have wound dehiscence from prior surgeries
Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption,gastrointestinal anastomosis, or any other condition that might affect theabsorption of palbociclib
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to the study agents
Prior history of grade >=3 immune-related adverse event(s) with checkpoint inhibitortherapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible
An active autoimmune disease. Note: participants with type 1 diabetes, eczema,vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiencyon systemic oral corticosteroid therapy (<= the equivalent of prednisone 10 mg/day)or other mild autoimmune disorders not requiring immunosuppressive treatment areeligible.
Participants receiving systemic corticosteroids at doses equivalent > 10 mg/daily ofprednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil,sirolimus, thalidomide, or anti-tumor necrosis factor [anti-TNF] agents. Note:participants on steroids through a route known to result in minimal systemicexposure (topical, intranasal, intro-ocular, or inhalation) are eligible
Prior allogeneic/autologous bone marrow or solid organ transplant
Participants with current or past hepatitis B (HBV) infection
Participants with a history of interstitial lung disease, non-infectiouspneumonitis, or active/latent pulmonary tuberculosis (TB)
Participants taking medications that are strong inhibitors or inducers of CYP3A (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions-table-substrates-inhibitors-and-inducers#table3-2) within 21 days or 5half-lives of the agent (whichever is shorter) prior to initiation of study therapy
Participants taking any herbal supplements within 14 days prior to initiation ofstudy therapy
History of a non RCC malignancy within 2 years of treatment initiation except forthe following: adequately treated localized skin cancer, ductal carcinoma in situ,cervical carcinoma in situ, superficial bladder cancer, or other malignancy whichdoes not require treatment at the current time per Standard of Care
Pregnant women (confirmed by <=-HCG serum pregnancy test performed at screening)
Uncontrolled intercurrent illness that would limit compliance with studyrequirements evaluated by history, physical exam, and chemistry panel
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
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