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DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

Primary Purpose

Carcinoma, Renal Cell

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DFF332
RAD001
PDR001
NIR178
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring ccRCC, RCC, Kidney, DFF332, NIR178, PDR001, RAD001, Everolimus, Spartalizumab, Taminadenant, Von Hippel-Lindau Disease, Hereditary leiomyomatosis and renal cell cancer syndrome, Paraganglioma, Pheochromocytoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female ≥ 18 years of age For Arm 1B: Male and female of age ≥ 12 years of age
  2. Histologically confirmed and documented clear cell renal cell carcinoma (ccRCC). Disease must be measurable as determined by RECIST v1.1.

    For Arm 1B: histologically confirmed and documented malignancies in the context of the following cancer predisposing syndromes/disorders or harboring somatic mutations on one of these genes:

    • Malignancies with VHL mutations (e.g. Von Hippel-Lindau disease)
    • Malignancies with FH mutations (e.g. Hereditary leiomyomatosis and renal cell carcinoma)
    • Malignancies with mutations in SDHD, SDHAF2, SDHC, SDHB, SDHA (e.g. Hereditary paraganglioma and pheochromocytoma syndrome)
    • Malignancies with EPAS1/HIF2A mutations
    • Malignancies with ELOC/TCEB1 mutations Note: Mutations must have been previously identified through local molecular assays.
  3. Patient with unresectable, locally advanced or metastatic ccRCC with documented disease progression following all standard of care therapy, including PD-1/L1 checkpoint inhibitor and a VEGF targeted therapy as monotherapy or in combination.

    Escalation: No restriction on the number of prior treatments Expansion (with the exception of Arm 1B): Up to 3 prior lines of treatment for advanced/metastatic disease For Arm 1B: Patients must have either metastatic disease or locally advanced disease that is unresectable or that patients be unfit for resection or other treatment modalities. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, and have no available therapies of proven clinical benefit; or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.

  4. For patients age ≥ 16 years: ECOG performance status ≤ 1 For patients age ≥ 12 and < 16 years: Lansky performance status ≥ 70

Exclusion Criteria:

  1. History of seizure disorder & extrapyramidal (EPS) symptoms
  2. Impaired cardiac function or clinically significant cardiac disease, including any of the following:

    • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension
    • Patients with corrected QT using the Fridericia's correction (QTcF) > 470 msec for all patients on screening ECG or congenital long QT syndrome Acute myocardial infarction or unstable angina < 3 months prior to study entry
    • History of stroke or transient ischemic event requiring medical therapy
    • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
  3. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:

    1. ≤ 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
    2. ≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
    3. ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin C.
    4. ≤ 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
    5. Patients who have undergone major surgery ≤ 4 weeks prior to first dose of study treatment or who have not recovered for the surgical procedure.
  4. Patient previously treated with a HIF2α inhibitor.
  5. Uncontrolled concurrent illness including, but not limited to, ongoing active infection, uncontrolled hypertension, active peptic ulcer disease or gastritis, active bleeding diatheses, including any Patient known to have evidence of acute or chronic hepatitis B, hepatitis C, human immunodeficency virus (HIV), or a psychiatric illness/social situation that in the investigator's opinion would limit compliance with study requirements or compromise the ability of the patient to give written informed consent. Patients with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed in the expansion parts but not in the escalation parts.
  6. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
  7. Presence of Grade ≥ 2 toxicity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAEv5.0), from prior cancer therapy with the exception of neuropathy (inclusion of patients with neuropathy of Grade 2 or less is permitted), ototoxicity, and alopecia.
  8. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • City of Hope National MedicalRecruiting
  • Massachusetts General Hospital .Recruiting
  • Washington University School Main CenterRecruiting
  • Memorial Sloan Kettering Cancer Center .Recruiting
  • Uni of TX MD Anderson Cancer Cntr Dept.ofMDAndersonCancerCtr(8)Recruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1 Dose Escalation DFF332

Arm 2 Dose Escalation DFF332 + Everolimus

Arm 3 Dose Escalation DFF332 + Spartalizumab + Taminadenant

Arm 1a Dose Expansion DFF332 in ccRCC

Arm 1b Dose Expansion DFF332 in HIF stabilizing malignancies

Arm 2a Dose Expansion DFF332 + Everolimus in ccRCC

Arm 3a Dose Expansion DFF332 + Spartalizumab + Taminadenant in ccRCC

Arm Description

DFF332 Single Agent

Combination treatment DFF332 + Everolimus

Combination treatment DFF332 + Spartalizumab + Taminadenant

DFF332 Single Agent in patients with ccRCC (age 18 years old and above)

DFF332 Single Agent in patients with HIF stabilizing malignancies (age 12 years old and above)

Combination treatment DFF332 + Everolimus in patients with ccRCC (age 18 years old and above)

Combination treatment DFF332 + Spartalizumab + Taminadenant in patients with ccRCC (age 18 years old and above)

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs/SAEs to characterize the safety and tolerability of DFF332 as a single agent, in combination with Everolimus (RAD001), and in combination with Spartalizumab (PDR001) plus Taminadenant (NIR178) in patients with advanced clear cell Renal Cell Carcinoma (ccRCC) and advanced malignancies with Hypoxia Inducible Factor (HIF) stabilizing mutations
Number of participants with dose interruptions and dose reductions
Number of participants with dose interruptions and dose reductions to characterize the tolerability of DFF332 as a single agent, in combination with Everolimus (RAD001), and in combination with Spartalizumab (PDR001) plus Taminadenant (NIR178) in patients with advanced ccRCC and advanced malignancies with HIF stabilizing mutations.
Dose intensity for DFF332 for dose escalation and expansion
Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure
Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 days) for DFF332 as a single agent and in combinations
Number of participants with DLTs

Secondary Outcome Measures

Overall Response Rate (ORR)
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Best Overall Response (BOR)
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Progression Free Survival (PFS) for Recommended Dose (RD) only
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Duration of Response (DOR) for Recommended Dose (RD) Only
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Disease Control Rate (DCR)
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Maximum Concentration (Cmax) of DFF332 single agent and combination
PK parameters will be based on plasma concentration of DFF332 and Taminadenant, whole blood concentration of Everolimus, serum concentration of Spartalizumab
Area under the concentration-time curve (AUC) of DFF332 single agent and combination
PK parameters will be based on plasma concentration of DFF332 single agent and in combination.

Full Information

First Posted
May 19, 2021
Last Updated
July 12, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04895748
Brief Title
DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies
Official Title
A Phase I/Ib, Open-label, Multi-center Study of DFF332 as a Single Agent and in Combination With Everolimus or IO Agents in Patients With Advanced/Relapsed ccRCC and Other Malignancies With HIF2α Stabilizing Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
April 29, 2025 (Anticipated)
Study Completion Date
April 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 will be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.
Detailed Description
This is a first in human (FIH), Phase I/Ib, open-label, multi-center study of DFF332 as a single agent and in combination with Everolimus or Spartalizumab plus Taminadenant in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations. The study consists of two parts, dose escalation and dose expansion. The dose escalation part of the study will initially evaluate DFF332 single agent. Dose escalation groups receiving DFF332 in combination with Everolimus or DFF332 in combination with Spartalizumab plus Taminadenant will open after at least two dose levels of single agent DFF332 have been evaluated. The dose expansion part of single agent will include two treatment arms: Arm1A will enroll ccRCC patients (age 18 yo or above) and Arm1B will enroll patients with malignancies harboring HIF stabilizing mutations (age 12 yo and above). These include the following: Malignancies with VHL mutations (e.g. Von Hippel-Lindau disease) Malignancies with FH mutations (e.g. Hereditary leiomyomatosis and renal cell carcinoma) Malignancies with mutations in SDHD, SDHAF2, SDHC, SDHB, SDHA (e.g. Hereditary paraganglioma and pheochromocytoma syndrome) Malignancies with EPAS1/HIF2A mutations Malignancies with ELOC/TCEB1 mutations The expansion part of the combination therapies will enroll patients with ccRCC and include Arm2A (DFF332 with Everolimus) and Arm3A (DFF332 with Spartalizumab plus Taminadenant).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
ccRCC, RCC, Kidney, DFF332, NIR178, PDR001, RAD001, Everolimus, Spartalizumab, Taminadenant, Von Hippel-Lindau Disease, Hereditary leiomyomatosis and renal cell cancer syndrome, Paraganglioma, Pheochromocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Dose Escalation DFF332
Arm Type
Experimental
Arm Description
DFF332 Single Agent
Arm Title
Arm 2 Dose Escalation DFF332 + Everolimus
Arm Type
Experimental
Arm Description
Combination treatment DFF332 + Everolimus
Arm Title
Arm 3 Dose Escalation DFF332 + Spartalizumab + Taminadenant
Arm Type
Experimental
Arm Description
Combination treatment DFF332 + Spartalizumab + Taminadenant
Arm Title
Arm 1a Dose Expansion DFF332 in ccRCC
Arm Type
Experimental
Arm Description
DFF332 Single Agent in patients with ccRCC (age 18 years old and above)
Arm Title
Arm 1b Dose Expansion DFF332 in HIF stabilizing malignancies
Arm Type
Experimental
Arm Description
DFF332 Single Agent in patients with HIF stabilizing malignancies (age 12 years old and above)
Arm Title
Arm 2a Dose Expansion DFF332 + Everolimus in ccRCC
Arm Type
Experimental
Arm Description
Combination treatment DFF332 + Everolimus in patients with ccRCC (age 18 years old and above)
Arm Title
Arm 3a Dose Expansion DFF332 + Spartalizumab + Taminadenant in ccRCC
Arm Type
Experimental
Arm Description
Combination treatment DFF332 + Spartalizumab + Taminadenant in patients with ccRCC (age 18 years old and above)
Intervention Type
Drug
Intervention Name(s)
DFF332
Intervention Description
Hif2alpha inhibitor
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
Everolimus
Intervention Description
mTOR inhibitor
Intervention Type
Drug
Intervention Name(s)
PDR001
Other Intervention Name(s)
Spartalizumab
Intervention Description
anti-PD-1
Intervention Type
Drug
Intervention Name(s)
NIR178
Other Intervention Name(s)
Taminadenant
Intervention Description
Adenosine A2A antagonist receptor
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Description
Number of participants with AEs/SAEs to characterize the safety and tolerability of DFF332 as a single agent, in combination with Everolimus (RAD001), and in combination with Spartalizumab (PDR001) plus Taminadenant (NIR178) in patients with advanced clear cell Renal Cell Carcinoma (ccRCC) and advanced malignancies with Hypoxia Inducible Factor (HIF) stabilizing mutations
Time Frame
3 years
Title
Number of participants with dose interruptions and dose reductions
Description
Number of participants with dose interruptions and dose reductions to characterize the tolerability of DFF332 as a single agent, in combination with Everolimus (RAD001), and in combination with Spartalizumab (PDR001) plus Taminadenant (NIR178) in patients with advanced ccRCC and advanced malignancies with HIF stabilizing mutations.
Time Frame
3 years
Title
Dose intensity for DFF332 for dose escalation and expansion
Description
Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure
Time Frame
3 years
Title
Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 days) for DFF332 as a single agent and in combinations
Description
Number of participants with DLTs
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Time Frame
3 years
Title
Best Overall Response (BOR)
Description
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Time Frame
3 years
Title
Progression Free Survival (PFS) for Recommended Dose (RD) only
Description
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Time Frame
3 years
Title
Duration of Response (DOR) for Recommended Dose (RD) Only
Description
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Time Frame
3 years
Title
Disease Control Rate (DCR)
Description
To assess the anti-tumor activity of DFF332 as single agent and combination in patients with advanced ccRCC and with advanced malignancies with HIF stabilizing mutations based on RECIST v1.1
Time Frame
3 years
Title
Maximum Concentration (Cmax) of DFF332 single agent and combination
Description
PK parameters will be based on plasma concentration of DFF332 and Taminadenant, whole blood concentration of Everolimus, serum concentration of Spartalizumab
Time Frame
3 years
Title
Area under the concentration-time curve (AUC) of DFF332 single agent and combination
Description
PK parameters will be based on plasma concentration of DFF332 single agent and in combination.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female ≥ 18 years of age For Arm 1B: Male and female of age ≥ 12 years of age Histologically confirmed and documented clear cell renal cell carcinoma (ccRCC). Disease must be measurable as determined by RECIST v1.1. For Arm 1B: histologically confirmed and documented malignancies in the context of the following cancer predisposing syndromes/disorders or harboring somatic mutations on one of these genes: Malignancies with VHL mutations (e.g. Von Hippel-Lindau disease) Malignancies with FH mutations (e.g. Hereditary leiomyomatosis and renal cell carcinoma) Malignancies with mutations in SDHD, SDHAF2, SDHC, SDHB, SDHA (e.g. Hereditary paraganglioma and pheochromocytoma syndrome) Malignancies with EPAS1/HIF2A mutations Malignancies with ELOC/TCEB1 mutations Note: Mutations must have been previously identified through local molecular assays. Patient with unresectable, locally advanced or metastatic ccRCC with documented disease progression following all standard of care therapy, including PD-1/L1 checkpoint inhibitor and a VEGF targeted therapy as monotherapy or in combination. Escalation: No restriction on the number of prior treatments Expansion (with the exception of Arm 1B): Up to 3 prior lines of treatment for advanced/metastatic disease For Arm 1B: Patients must have either metastatic disease or locally advanced disease that is unresectable or that patients be unfit for resection or other treatment modalities. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, and have no available therapies of proven clinical benefit; or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy. For patients age ≥ 16 years: ECOG performance status ≤ 1 For patients age ≥ 12 and < 16 years: Lansky performance status ≥ 70 Exclusion Criteria: History of seizure disorder & extrapyramidal (EPS) symptoms Impaired cardiac function or clinically significant cardiac disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension Patients with corrected QT using the Fridericia's correction (QTcF) > 470 msec for all patients on screening ECG or congenital long QT syndrome Acute myocardial infarction or unstable angina < 3 months prior to study entry History of stroke or transient ischemic event requiring medical therapy Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes: ≤ 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment. ≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent. ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin C. ≤ 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists. Patients who have undergone major surgery ≤ 4 weeks prior to first dose of study treatment or who have not recovered for the surgical procedure. Patient previously treated with a HIF2α inhibitor. Uncontrolled concurrent illness including, but not limited to, ongoing active infection, uncontrolled hypertension, active peptic ulcer disease or gastritis, active bleeding diatheses, including any Patient known to have evidence of acute or chronic hepatitis B, hepatitis C, human immunodeficency virus (HIV), or a psychiatric illness/social situation that in the investigator's opinion would limit compliance with study requirements or compromise the ability of the patient to give written informed consent. Patients with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed in the expansion parts but not in the escalation parts. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment. Presence of Grade ≥ 2 toxicity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAEv5.0), from prior cancer therapy with the exception of neuropathy (inclusion of patients with neuropathy of Grade 2 or less is permitted), ototoxicity, and alopecia. Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
+1 626 256 4673 Ext 85013
First Name & Middle Initial & Last Name & Degree
Sumanta Kumar Pal
Facility Name
Massachusetts General Hospital .
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnifer Petersen
Email
wpetersen@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Xin Gao
Facility Name
Washington University School Main Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Reilly
Phone
314-454-8293
Email
areilly@wustl.edu
First Name & Middle Initial & Last Name & Degree
Joel Picus
Facility Name
Memorial Sloan Kettering Cancer Center .
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kira Vom Eigen
Email
vomeigek@mskcc.org
First Name & Middle Initial & Last Name & Degree
Ritesh R Kotecha
Facility Name
Uni of TX MD Anderson Cancer Cntr Dept.ofMDAndersonCancerCtr(8)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Brooks
Phone
713-563-7231
Email
mrbrooks@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Nizar Tannir
Facility Name
Novartis Investigative Site
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koto ku
State/Province
Tokyo
ZIP/Postal Code
135 8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

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