colorectaal kanker (muv mismatch repair deficienties), non-small cell long kanker (adenocarcinoma) en triple negatieve borstkanker and breast cancer non-familial colorectal cancer NSCLC RCC
Conditions
Interventions
Treatment with PDR001 IV 400 mg in combination with the following oral
treatments in the following doses:
LCL161:
Start: 300 mg/week,
-1: 300mg/4 weeks,
+1: 900mg/week.
Everolimus:
Start: 5 mg/w
Everolimus
Panabionstat
PDR001
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Female and male patients >= 18 years old. • Subjects, who have progressed despite standard therapy or are intolerant to standard therapy, or for whom no standard therapy exists. Diagnosis CRC, NSCLC, TNBC, TP53 wt CRC and TP53 wt RCC. See protocol page 39 for details. • ECOG performance status 0-1. • Disease amenable to biopsy and a candidate for tumor biopsy according to the treating institution*s guidelines. Patient must be willing to undergo a new tumor biopsy at baseline, and during therapy on this study. • Prior therapy with PD-1/PDL-1 inhibitors is allowed. See protocol page 40 for details.
Exclusion criteria
Exclusion criteria: • History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs). • Patients with known hypersensitivity to any of the components of investigational treatment will be excluded from participation in the corresponding arm. Patients that have a history of hypersensitivity to rapamycin derivatives will be excluded from participation in the everolimus arm • History of or current drug-induced interstitial lung disease or pneumonitis grade >=2 • Symptomatic CNS metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks. • Out of range laboratory values. See protocol page 40 for details. Impaired cardiac function or clinically significant cardiac disease. See protocol page 40 for details. • Active autoimmune disease, infection requiring antibiotics. • HBV or HCV infection. Known HIV infection. See protocol page 41 for details. • Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. See protocol page 41 for details. • Treatment with systemic steroid therapy, other than in the setting of adrenal insufficiency, systemic immunosuppressive therapy. • Life vaccines against infectious diseases within 4 weeks of initiation of study treatment. • Major surgery within 2 weeks. See protocol page 41 for details. • Radiotherapy within 2 weeks, except for palliative radiotherapy to a limited field. • CSF within 3 weeks. See protocol page 41 for details. • Pregnancy, lactation, insufficient contraception for females of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, dose limiting toxicities, dose interruptions and reductions, dose intensities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor infiltrating lymophocytes, ECGs, Best overall response, treatment free survival, PK parameters, anti-PDR001 antibodies. | — |
Countries
The Netherlands
Outcome results
None listed