Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab
- Conditions
- Melanoma Stage IIIMelanoma
- Registration Number
- NCT04013854
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> - The subject must have clinical stage III resectable melanoma per investigator.<br> Subjects may not have a diagnosis of uveal or mucosal melanoma.<br><br> - Either the subject or the subject's legally authorized representative must be<br> willing and able to provide written informed consent before the performance of any<br> protocol-related procedures.<br><br> - The subject must be =18 years of age on day of signing informed consent.<br><br> - The subject must have a performance status of 0 or 1 on the ECOG Performance Scale.<br><br> - The subject must demonstrate adequate organ function as defined in Table 1; all<br> screening labs must be performed within 28 days of treatment initiation.<br><br> - Hematologic System: Absolute neutrophil count (ANC) =1500/mcL; Platelets<br> =100,000/mcL; Hemoglobin =9 g/dL or =5.6 mmol/L<br><br> - Renal System: Serum creatinine OR measured or calculated creatinine clearance<br> (GFR can also be used in place of creatinine or CrCl) =1.5 X upper limit of<br> normal (ULN) OR =50 mL/min for subject with creatinine levels >1.5 X<br> institutional ULN<br><br> - Hepatic System: Serum total bilirubin =1.5 X ULN OR Direct bilirubin = ULN for<br> subjects with total bilirubin levels >1.5 ULN; AST (SGOT) and ALT (SPGT) =2.5 X<br> ULN OR =5 X ULN for subjects with liver metastases<br><br> - A female participant is eligible to participate if she is not pregnant (see Appendix<br> 3), not breastfeeding, and at least one of the following conditions applies: A.) Not<br> a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR B.) A WOCBP<br> who agrees to follow the contraceptive guidance in Appendix 3 during the treatment<br> period and is willing to use a highly effective method of contraception or abstain<br> from heterosexual intercourse for at least 2 weeks prior to the time of first dose<br> of study medication through 5 months after the last dose of study medication.<br><br> - Female subjects of childbearing potential must have a negative urine or serum<br> pregnancy test within 72 hours prior to receiving the first dose of study<br> medication.<br><br> - Male subjects must agree to follow the contraceptive guidance in Appendix 3 starting<br> with the first dose of study medication, while on study, through 7 months after the<br> last dose of study medication.<br><br>Exclusion Criteria:<br><br> - Subject has unresectable disease; i.e. in the opinion of the surgical oncologist,<br> all of the subject's melanoma cannot be completely removed with a clear margin.<br><br> - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or<br> with an agent directed to another stimulatory or co-inhibitory T-cell receptor<br> (e.g., CTLA-4, OX 40, CD137), interferon, high dose IL-2 or any other antibody or<br> drug specifically targeting T-cell co-stimulation or checkpoint pathways.<br><br> - Has received prior systemic anti-cancer therapy including investigational agents<br> within 4 weeks prior to the first dose of study drug. Note: Participants must have<br> recovered from all AEs due to previous therapies to =Grade 1 or baseline.<br> Participants with =Grade 2 neuropathy are an exception to this criterion.<br><br> - If participant received major surgery, they must have recovered adequately from the<br> toxicity and/or complications from the intervention prior to starting study<br> treatment.<br><br> - Subject has received transfusion of blood products (including platelets or red blood<br> cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or<br> recombinant erythropoietin) within 4 weeks to the first dose of study drug.<br><br> - Has received a live vaccine within 30 days prior to the first dose of study drug.<br> Examples of live vaccines include, but are not limited to, the following: measles,<br> mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus<br> Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for<br> injection are generally killed virus vaccines and are allowed; however, intranasal<br> influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not<br> allowed.<br><br> - Is currently participating in or has participated in a study of an investigational<br> agent or has used an investigational device within 4 weeks prior to the first dose<br> of study treatment.<br><br> - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy<br> (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of<br> immunosuppressive therapy within 7 days prior to the first dose of study drug.<br><br> - Has a known additional malignancy that is progressing or requires active treatment.<br> Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of<br> the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that<br> have undergone potentially curative therapy are not excluded.<br><br> - Has active autoimmune disease that has required systemic treatment in the past 3<br> months (i.e. with use of disease modifying agents, corticosteroids or<br> immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or<br> physiologic corticosteroid replacement therapy for adrenal or pituitary<br> insufficiency, etc.) is not considered a form of systemic treatment.<br><br> - Has evidence of active interstitial lung disease or a history of (non-infectious)<br> pneumonitis that required steroids or has current pneumonitis.<br><br> - Has an active infection requiring systemic therapy.<br><br> - Patients known to be positive for Human Immunodeficiency Virus (HIV) if they have a<br> CD4 count of less than 350 mm3 and a serum HIV viral load > 25,000 IU/mL<br><br> - Has active Hepatitis B infection or active Hepatitis C virus infection as determined<br> by medical record review.<br><br> - Has a history or current evidence of any condition, therapy, or laboratory<br> abnormality that might confound the results of the study, interfere with the<br> subject's participation for the full duration of the study, or is not in the best<br> interest of the subject to participate, in the opinion of the treating investigator.<br><br> - Has known psychiatric or substance abuse disorders that would interfere with<br> cooperation with the requirements of the trial.<br><br> - Is pregnant or breastfeeding, or expecting to conceive or father children within the<br> projected duration of the study, starting with the screening visit through 5 months,<br> if female, or 7 months, if male, after the last dose of investigational drug.<br><br> - Prisoners or subjects who are involuntarily incarcerated.<br><br> - Subjects who are compulsorily detained for treatment of either a psychiatric or<br> physical (eg, infectious disease) illness.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence-Free Survival
- Secondary Outcome Measures
Name Time Method Frequency and Incidence of Adverse Events;Pathological Response Rate;Overall Survival