Oligometastatic renal cell carcinoma MedDRA version: 21.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: KEYTRUDA (pembrolizumab, MK3475)
Product Name: .
Product Code: [.]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
CAS Number: 1374853-91-4
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Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of clear cell renal cell carcinoma will be enrolled in this study. 2. Have undergone a partial nephrectomy or radical complete nephrectomy with negative surgical margins. 3. Evidence of oligo-metastatic disease eligible for local treatment with radiotherapy or surgery, defined as: a) Appearance of new metastases within 5 years from previous eradication of primary tumors or previous metastasectomy. b) Presence of maximum 3 metastases in the same site or in different sites with the exception of bone metastases that cannot exceed the number of 2 if they are the sole disease site or one in case of multiple sites. c) Each metastasis should be less than 3 cm in the maximum diameter and less than 5 cm in the sum of the longest tumor diameters (this evaluation should apply also for lymph nodes). 4. Has received no prior systemic therapy for RCC. 5. Has ECOG performance status of 0 to 1 within 7 days of before the start of study intervention. 6. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. 7. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a primary tumor or tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide. Newly obtained biopsies are preferred to archived tissue. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding 9 . Adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41
Exclusion criteria
Exclusion criteria: 1. Has had major surgery, other than nephrectomy, within 4 weeks prior to randomization. 2. Has residual thrombus post nephrectomy in the vena renalis or vena cava. 3. 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). 4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. 5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, undergone CABG or PTCA, or cardiac arrhythmia. 6. Has moderate to severe hepatic impairment (Child-Pugh B or C). 7. 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. 8. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. 9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, prostate cancer pT2 or less, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 12. Has known active CNS metastases and/or carcinomatous meningitis. 13. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients. 14. Has active autoimmune disease that has required systemic treatment in the past 2 years . Replacement therapy is not considered a form of systemic treatment and is allowed. 15. Has a history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 16. Has an active infection requiring systemic therapy. 17. Has a known history of Human Immunodeficiency Virus (HIV) infection. 18. Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. 19. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 20. Has known psychiatric or substance abuse disorders that would interfere with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the relapsed free survival (RFS) defined as the length of time from the randomization and the appearance of radiological progression of kidney cancer in patients who received pembrolizumab compared to those who did not.;Secondary Objective: •To assess the distant relapsed free survival (dRFS) in patients who received pembrolizumab compared to those who did not. The dRFS was defined as the length of time from the randomization to the appearance of distant metastases outside those treated with surgery or radiotherapy. •To assess the overall survival defined as the time from the randomization to the patient’s death or last contact in patients who received pembrolizumab compared to those who did not. •To assess the overall incidence of adverse events in patients who received pembrolizumab compared to those who did not. •To assess the overall incidence local progression in patients who received pembrolizumab plus RT compared to those who received RT alone.;Primary end point(s): To assess the relapsed free survival (RFS) defined as the length of time from the randomization and the appearance of radiological progression of kidney cancer in patients who received pembrolizumab compared to those who did not.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the distant relapsed free survival (dRFS) in patients who received pembrolizumab compared to those who did not. The dRFS was defined as the length of time from the randomization to the appearance of distant metastases outside those treated with surgery or radiotherapy. • To assess the overall survival defined as the time from the randomization to the patient’s death or last contact in patients who received pembrolizumab compared to those who did not. • To assess the overall incidence of adverse events in patients who received pembrolizumab compared to those who did not. • To assess the overall incidence local progression in patients who received pembrolizumab plus RT compared to those who received RT alone;Timepoint(s) of evaluation of this end point: - continuous -every 12 weeks during the treatment - continuous -every 6 weeks during the treatment - continuous -every 6 weeks during the treatment -continuous -every 12 weeks during the treatment | — |
Countries
Italy
Contacts
Public ContactArea Gastroenterologia e Oncologia
Roberto Iacovelli
Outcome results
None listed