A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat
The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 11, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Biological: PDR001; Drug: LCL161; Drug: Everolimus; Drug: Panobinostat; Drug: QBM076; Drug: HDM201
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Written informed consent prior to any procedure
- Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant to SOC, or for whom no standard therapy exists. Patients must fit into one of the following groups:
- CRC •NSCLC
- TNBC
- RCC
- ECOG ≤ 2
- Patient must have a site of disease for biopsy, and be a candidate for tumor biopsy according to the institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.
- Prior therapy with PD-1/PDL-1 inhibitors is allowed provided any toxicity attributed to prior PD-1- or PD-L1-directed therapy did not lead to discontinuation of therapy.
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy within prior 2 weeks.
- Patients with known hypersensitivity to any of the components of an investigational treatment will be excluded from participation in the corresponding arm but are eligible for participation in other study 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
- Out of range lab values as defined in protocol
- Impaired cardiac function or clinically significant cardiac disease
- Active, known or suspected autoimmune disease
- Human Immunodeficiency Virus (HIV), or active Hepatitis C (HCV) virus. Escalation: active Hepatitis B (HBV); Expansion: Patients with Chronic HBV currently on medication will not be excluded.
- Impairment of gastrointestinal (GI) function
- Malignant disease, other than that being treated in this study
- Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and washout period is 6 weeks; prior immunotherapy - washout is 4 weeks
- Active infection requiring systemic antibiotic therapy.
- Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids or treatment with low, stable dose of steroid (\<10 mg/day prednisone or equivalent) for stable CNS metastatic disease.
- Patients receiving systemic treatment with any immunosuppressive medication.
- Major surgery within 2 weeks of the first dose of study treatment
- Radiotherapy within 2 weeks of the first dose of study drug
- Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
- Presence of ≥ CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ CTCAE grade 3) due to prior therapy.
- Use of hematopoietic colony stimulating growth factors \</= 3 weeks prior to first dose Additional
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Santa Monica Hematology / Oncology SCSanta Monica, California
- Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- The Regents of the University of MichiganAnn Arbor, Michigan
- Washington University Medical School SCSt Louis, Missouri
- University of Texas MD Anderson Cancer CenterHouston, Texas
- UT Health San Antonio Mays Cancer CenterSan Antonio, Texas
- Huntsman Cancer InstituteSalt Lake City, Utah
- Seattle Cancer Care AllianceSeattle, Washington
- Novartis Investigative SiteJena
- Novartis Investigative SiteUlm
- Novartis Investigative SiteWürzburg
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 11, 2023. Always confirm current availability with the study team.