Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CPDR001X2102)

Completed

• Conditions: 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; 10006291; 10029107

• Registration Number: NL-OMON47909
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 43

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events, dose limiting toxicities, dose interruptions and reductions,<br /><br>dose intensities.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tumor infiltrating lymophocytes, ECGs, Best overall response, treatment free<br /><br>survival, PK parameters, anti-PDR001 antibodies.</p><br>