This study has been transitioned to CTIS with ID 2022-501251-81-00 check the CTIS register for the current data. To compare disease free and overall survival of RCC patients, after adjuvant treatment with pembrolizumab after surgical renal resection…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease free survival (DFS)
Secondary outcome
Adverse Events
First local recurrence
DFS / OS in relation to PD-L1 expression
Quality of life, functional (dis)ability, disease related symptoms as reported
by the patient
Background summary
Renal cell carcinoma (RCC) is a relatively prevalent disease. Worldwide, there
are an estimated 209.000 newly diagnosed cases and an estimated 102.000 deaths
per year. Amongst others, because of the risk factors (smoking and obesity),
the incidence of this type of cancer has been increasing in the past decades.
Treatment generally consists of radical surgical resection, but a percentage of
these patients will have recurrence. The estimated 5-year survival of subjects
with localized RCC is approximately 90%. This percentage decreased to 65% in
locally advanced RCC and only 12% in metastatic RCC.
Apart from radical surgical resection, no viable adjuvant treatment options are
currently available, but there are indications that immune therapy could
potentially have a positive effect on disease free survival and overall
survival (DFS and OS). The therapy is usually well tolerated. The objective of
this study is to demonstrate a positive effect of immune therapy on DFS and OS
in patients with median-high to high risk on recurrent disease, after renal
resection.
Study objective
This study has been transitioned to CTIS with ID 2022-501251-81-00 check the CTIS register for the current data.
To compare disease free and overall survival of RCC patients, after adjuvant
treatment with pembrolizumab after surgical renal resection. The objective of
the study is to demonstrate that treatment with pembrolizumab, in comparison to
placebo, will show a positive effect on DFS and OS.
Study design
This is a double-blind placebo-controlled randomized study. Subjects will be
randomized to one of two treatments groups, either placebo or pembrolizumab.
Patients will receive up to 17 treatment cycles with the study medication and
will be entering long term follow up after treatment conclusion.
Intervention
3-week treatment cycles with pembrolizumab or placebo
Study burden and risks
For this study, patients will be subjected to invasive procedures such as blood
collection, IV line insertion, CT-MRI or bone scans, physical exams, possibly
confrontational questionnaires, and patients will be asked to visit the
hospital regularly. Patients will be administered with pembrolizumab or placebo
through an IV line, during three-week cycles, up to a maximum of 17 treatments.
Patients receiving pembrolizumab might experience a positive treatment effect,
however, this is not certain. For patients receiving placebo, no therapeutic
effect is foreseen.
For this group of patients, there are currently no adjuvant treatment options
available. Chemotherapy and radiotherapy are not effective in treatment of RCC.
Management consists of regular follow up. In the standard of care setting,
blood testing and scans are used to monitor the disease. Treatment with the
investigational drug and risks of side effects thereof, as well as the
questionnaires, are additional in comparison to standard treatment.
Pembrolizumab has an acceptable risk profile and is well tolerated. The results
of this study will contribute to more knowledge of the treatment of RCC and
will hopefully lead to more options for treatment of this patient group.
Waarderweg 39
Haarlem 2031 BN
NL
Waarderweg 39
Haarlem 2031 BN
NL
Listed location countries
Age
Inclusion criteria
1. Histologically confirmed diagnosis of RCC with clear cell component with or
without sarcomatoid features. Diagnosis of RCC with clear cell component is to
be made
by the investigator and does not require central histology review.
2. Be >= 18 years of age on day of signing informed consent.
Female Participants:
3. Female participants of childbearing potential must have a negative urine or
serum
pregnancy test within 72 hours prior to randomization.
4. 5. Use of acceptable contraception for the duration of the study (from first
dose until 120 days after last dose of study medication).
6. Written informed consent/assent for the trial.
7. Intermediate high-risk, high-risk, or M1 NED RCC as defined by protocol.
8. Have received no prior systemic therapy for advanced RCC
9. Have undergone a partial nephroprotective or radical complete nephrectomy
incl metastases, with negative surgical margins
Exclusion criteria
1. Has had major surgery, other than nephrectomy and/or resection of
pre-existing
metastases for M1 NED participants, within 12 weeks prior to randomization.
Note: If participants received major surgery, they must have recovered
adequately from
the toxicity and/or complications from the intervention prior to starting study
treatment.
2. Has received prior radiotherapy for RCC.
3. Has pre-existing brain or bone metastatic lesions.
4. Has residual thrombus post nephrectomy in the vena renalis or vena cava.
5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy or any other form of immunosuppressive therapy within 7 days prior the
first dose of study treatment.
6. Has an active autoimmune disease that has required systemic treatment in
past 2 years.
7. Has a known additional malignancy that is progressing or required active
treatment <=3
years ago. 8. Has a history of (non-infectious) pneumonitis that required
steroids or has current pneumonitis.
9. Has an active infection requiring systemic therapy.
10. Has a history of, or is currently on, dialysis
11. Has a known history of human immunodeficiency virus infection.
12. Has a known active hepatitis B or hepatitis C virus
13. Has a known history of active tuberculosis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-501251-81-00 |
| EudraCT | EUCTR2016-004351-75-NL |
| ClinicalTrials.gov | NCT03142334 |
| CCMO | NL67924.056.18 |