Avelumab/Gemcitabine in Sarcomatoid RCC

  • End date
    Jul 1, 2024
  • participants needed
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 2 March 2022


To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC.

Condition Metastatic sRCC
Treatment Gemcitabine, Avelumab
Clinical Study IdentifierNCT03483883
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on2 March 2022


Yes No Not Sure

Inclusion Criteria

Histologic evidence of metastatic RCC with sarcomatoid features (10% sarcomatoid component) or poor-risk RCC prognostic features (as defined by IMDC criteria). (14) An outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review
years of age
Phase I dose-escalation portion only
Patients must have 3 prior systemic treatment regimens with recent evidence of
disease progression by RECIST 1.1 criteria. Previous treatment with immune-
checkpoint inhibitor therapy is allowable as a line of systemic therapy for
the phase I portion. Prior systemic therapy in the adjuvant treatment setting
is allowable as a prior line of therapy
Phase Ib dose-expansion portion only
Patients must have been treated with 0 or 1 prior lines of systemic therapy
Previous treatment with immune-checkpoint inhibitor therapy is allowable as a
line of systemic therapy for the phase Ib expansion portion
No prior therapy with gemcitabine chemotherapy
ECOG performance status of 0-1. Patients must have primary or metastatic FFPE tissue available for histologic confirmation and possible determination of percent sarcomatoid component (if applicable)
Outside pathology report is sufficient for study eligibility. However
pathology should still be obtained as possible for internal institutional
pathology review
Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks
Patients must have normal organ function, as confirmed by laboratory values obtained 14 days prior to the first day of study therapy
Hematologic: Absolute neutrophil count (ANC) 1.5 109/L, platelet count 100
L, and hemoglobin 9 g/dL (may have been transfused) Hepatic: Total
bilirubin level 1.5 the upper limit of normal (ULN) range and AST and ALT
levels 2.5 ULN or AST and ALT levels 5 x ULN (for subjects with documented
metastatic disease to the liver)
Renal: Estimated creatinine clearance 45 mL/min using Cockroft Gault formula
Patients must have a projected life expectancy of at least 3 months
Pregnancy test: Negative serum or urine pregnancy test at screening for women
of childbearing potential
Contraception: Highly effective contraception for both male and female
subjects throughout the study and for at least 30 days after last avelumab
treatment administration if the risk of conception exists
In addition, women must not breastfeed while on this study as study drugs may
also affect a breast-feeding child. Pregnant women and women who are
breastfeeding are not allowed to participate in this study

Exclusion Criteria

IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypoor hyperthyroid diseases not requiring immunosuppressive treatment are eligible
ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation
INFECTIONS: Active infection requiring systemic therapy
HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome, or positive HIV test result at screening
HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
VACCINATION: Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines
HYPERSENSITIIVTY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade 3)
CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure ( New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade 2, or other Grade 2 not constituting a safety risk based on investigator's judgment are acceptable
Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
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