Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
LGK974, PDR001Tags
MSS/ MMRpComments
Porcupine (Wnt) inhibitor (LGK974) + PD1 (PDR001). BRAF mutant colorectal cancer specifically being recruited.
Phase I is expected to be Jan. 2019
| Location | Location Status |
|---|---|
| United States | |
|
UCLA School of Medicine Los Angeles, California 90024 |
Active, not recruiting |
|
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Baltimore, Maryland 21287-0013 |
Active, not recruiting |
|
Dana Farber Cancer Institute SC-7 Boston, Massachusetts 02215 |
Active, not recruiting |
|
University of Michigan Comprehensive Cancer Center Onc Dept. Ann Arbor, Michigan 48109-0944 |
Active, not recruiting |
|
Karmanos Cancer Institute Wayne St Detroit, Michigan 48201 |
Active, not recruiting |
|
University of Texas/MD Anderson Cancer Center MD Anderson 2 Houston, Texas 77030-4009 |
Active, not recruiting |
| Canada | |
|
Novartis Investigative Site Montreal, Quebec H2W 1T8 |
Active, not recruiting |
| France | |
|
Novartis Investigative Site Villejuif 94800 |
Active, not recruiting |
| Germany | |
|
Novartis Investigative Site Essen 45147 |
Active, not recruiting |
| Italy | |
|
Novartis Investigative Site Milano, MI 20133 |
Active, not recruiting |
|
Novartis Investigative Site Napoli 80131 |
Active, not recruiting |
| Netherlands | |
|
Novartis Investigative Site Rotterdam 3075 EA |
Active, not recruiting |
|
Novartis Investigative Site Utrecht 3584CX |
Active, not recruiting |
| Spain | |
|
Novartis Investigative Site Barcelona, Catalunya 08035 |
Active, not recruiting |
|
Novartis Investigative Site Barcelona, Catalunya 08036 |
Active, not recruiting |
|
Novartis Investigative Site Hospitalet de LLobregat, Catalunya 08907 |
Active, not recruiting |
|
Novartis Investigative Site Valencia, Comunidad Valenciana 46010 |
Active, not recruiting |
|
Novartis Investigative Site Madrid 28009 |
Active, not recruiting |
|
Novartis Investigative Site Madrid 28040 |
Active, not recruiting |
|
Novartis Investigative Site Madrid 28050 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
Diagnosis of locally advanced or metastatic cancer that has progressed despite standard therapy or for which no effective standard therapy exists and histological confirmation of one of the following diseases indicated below:
Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic adenocarcinoma. In addition, tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis.
Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43 mutation. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are eligible with prior agreement with Novartis
LGK974 with PDR001: Dose escalation: patients with the following cancers that were previously treated with anti-PD-1 therapy and whose best response on that therapy was progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior anti-PD-1 therapy.
LGK974 with PDR001: Dose expansion: patients with:
cutaneous melanoma that was primary refractory to prior anti-PD-1 therapy, defined as a best response of progressive disease or stable disease for 4 months. Patients with BRAF V600-mutant melanoma must have also received and been failed by prior systemic therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor.
Exclusion Criteria
Exclusion Criteria:
Impaired cardiac function
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LGK974 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
Brain metastases that have not been adequately treated
Malignant disease other than that being treated in this study
Laboratory abnormalities as specified in the protocol
Osteoporosis, osteopenia
Bone fractures within the past year
Pathologic bone fracture
Active, known or suspected autoimmune disease or severe hypersensitivity reactions to other monoclonal antibodies
Other protocol-defined inclusion/exclusion criteria may apply
