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Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002)

Primary Purpose

Renal Cell Carcinoma, Metastatic Castration-resistant Prostate Cancer, Urothelial Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
XL092
Nivolumab
Ipilimumab
Nivolumab
Nivolumab
Nivolumab + Relatlimab
Sponsored by
Exelixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.
  • Dose-Escalation Cohorts: Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
  • Expansion Cohort 1 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.

    • Note: Prior non-VEGF targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.
  • Expansion Cohort 2 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component.

    • Must have radiographically progressed after a combination therapy consisting of a PD-1/PD-L1 targeting mAb with a VEGFR-TKI or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.
    • Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.
  • Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.

    • Must have progressed during or after one NHT given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.
  • Expansion Cohort 4 (UC, ICI-naive): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).

    • Must have progressed during or after prior first-line platinum-based combination therapy, including subjects who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence < 12 months from the end of last therapy.
    • Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.
  • Expansion Cohort 5 (UC, ICI-experienced): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).

    • Must have progressed during or after prior PD-1/PD-L1 targeting ICI therapy given as monotherapy, combination therapy, maintenance therapy or adjuvant therapy.
    • Must have received no more than 2 prior lines of systemic anticancer therapy for unresectable advanced or metastatic disease.
  • Expansion Cohort 6 (nccRCC): Subjects with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary RCC (any type), unclassified RCC, and translocation-associated. Among the eligible histologic subtypes, sarcomatoid features are allowed.

    • No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.
  • Expansion Cohorts 1, 2, 4, 5, 6: Measurable disease per RECIST 1.1 as determined by the Investigator.
  • For expansion cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
  • Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
  • Karnofsky Performance Status (KPS) ≥ 70%.
  • Adequate organ and marrow function.
  • Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
  • Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

  • For all Dose-Escalation cohorts: Prior treatment with XL092. For all Expansion Cohorts: Prior treatment with XL092, nivolumab, or ipilimumab with the following exceptions: Prior PD-1/PD-L1 and CTLA-4 targeting therapy for locally advanced or metastatic disease is allowed for Cohorts 2 (ccRCC 2L) and 5 (UC [ICI-experienced]).
  • For all Dose-Escalation Cohorts and Expansion Cohorts 2 (ccRCC), 3 (mCRPC), 4 and 5 (UC): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
  • For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
  • For all Dose-Escalation Cohorts and Expansion Cohorts 2 (ccRCC), 3 (mCRPC), 4 and 5 (UC): Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.
  • Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
  • Prior external radiation therapy within 2 weeks and prior radium-223 therapy within 6 weeks before first dose of study treatment.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before first dose of study treatment.
  • Concomitant anticoagulation with oral anticoagulants and platelet inhibitors.
  • Administration of a live, attenuated vaccine within 30 days prior to enrollment.
  • Uncontrolled, significant intercurrent or recent illness.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment.
  • Subjects with inadequately treated adrenal insufficiency.
  • Pregnant or lactating females.
  • Any other active malignancy within two years before first dose of study treatment, except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Note: Additional Inclusion and Exclusion criteria may apply.

Sites / Locations

  • Exelixis Clinical Site #67Recruiting
  • Exelixis Clinical Site #1Recruiting
  • Exelixis Clinical Site #59Recruiting
  • Exelixis Clinical Site #62Recruiting
  • Exelixis Clinical Site #49Recruiting
  • Exelixis Clinical Site #48Recruiting
  • Exelixis Clinical Site #11Recruiting
  • Exelixis Clinical Site #47Recruiting
  • Exelixis Clinical Site #61
  • Exelixis Clinical Site #8Recruiting
  • Exelixis Clinical Site #26Recruiting
  • Exelixis Clinical Site #4Recruiting
  • Exelixis Clinical Site #14Recruiting
  • Exelixis Clinical Site #7Recruiting
  • Exelixis Clinical Site #65Recruiting
  • Exelixis Clinical Site #13Recruiting
  • Exelixis Clinical Site #68Recruiting
  • Exelixis Clinical Site #2Recruiting
  • Exelixis Clinical Site #5Recruiting
  • Exelixis Clinical Site #55Recruiting
  • Exelixis Clinical Site #60Recruiting
  • Exelixis Clinical Site #6Recruiting
  • Exelixis Clinical Site #12Recruiting
  • Exelixis Clinical Site #10Recruiting
  • Exelixis Clinical Site #51Recruiting
  • Exelixis Clinical Site #32Recruiting
  • Exelixis Clinical Site #24Recruiting
  • Exelixis Clinical Site #9Recruiting
  • Exelixis Clinical Site #3Recruiting
  • Exelixis Clinical Site #46Recruiting
  • Exelixis Clinical Site #70Recruiting
  • Exelixis Clinical Site #50Recruiting
  • Exelixis Clinical Site #66Recruiting
  • Exelixis Clinical Site #33Recruiting
  • Exelixis Clinical Site #16Recruiting
  • Exelixis Clinical Site #35Recruiting
  • Exelixis Clinical Site #42Recruiting
  • Exelixis Clinical Site #36Recruiting
  • Exelixis Clinical Site #31Recruiting
  • Exelixis Clinical Site #29Recruiting
  • Exelixis Clinical Site #39Recruiting
  • Exelixis Clinical Site #37Recruiting
  • Exelixis Clinical Site #64Recruiting
  • Exelixis Clinical Site #63Recruiting
  • Exelixis Clinical Site #72Recruiting
  • Exelixis Clinical Site #52Recruiting
  • Exelixis Clinical Site #71Recruiting
  • Exelixis Clinical Site #69Recruiting
  • Exelixis Clinical Site #38Recruiting
  • Exelixis Clinical Site #40Recruiting
  • Exelixis Clinical Site #30Recruiting
  • Exelixis Clinical Site #45Recruiting
  • Exelixis Clinical Site #20Recruiting
  • Exelixis Clinical Site #34Recruiting
  • Exelixis Clinical Site #28Recruiting
  • Exelixis Clinical Site #54Recruiting
  • Exelixis Clinical Site #23Recruiting
  • Exelixis Clinical Site #18Recruiting
  • Exelixis Clinical Site #41Recruiting
  • Exelixis Clinical Site #53Recruiting
  • Exelixis Clinical #15Recruiting
  • Exelixis Clinical Site #27Recruiting
  • Exelixis Clinical Site #17Recruiting
  • Exelixis Clinical Site #57Recruiting
  • Exelixis Clinical Site #43Recruiting
  • Exelixis Clinical Site #58Recruiting
  • Exelixis Clinical Site #19Recruiting
  • Exelixis Clinical Site #56Recruiting
  • Exelixis Clinical Site #25Recruiting
  • Exelixis Clinical Site #21Recruiting
  • Exelixis Clinical Site #22Recruiting
  • Exelixis Clinical Site #44Recruiting

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

XL092 + Nivolumab Dose-Escalation Cohorts

XL092 + Nivolumab + Ipilimumab Dose-Escalation Cohorts

XL092 + Nivolumab Expansion Cohorts

XL092 + Nivolumab + Ipilimumab Expansion Cohorts

XL092 Single-Agent Expansion Cohorts

XL092 + Nivolumab + Relatlimab Dose-Escalation Cohorts

XL092 + Nivolumab + Relatlimab Expansion Cohorts

Arm Description

Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.

Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs)
To evaluate the safety of XL092 when administered alone or in combination therapy regimens through the evaluation of incidence and severity of AEs and SAEs, including imAEs
Expansion Stage: Objective Response Rate (ORR)
To evaluate ORR in subjects with measurable disease as assessed by the Investigator per RECIST 1.1
Expansion Stage: Progression-Free Survival (PFS)
For Cohort 3 (mCRPC): To evaluate duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria (Scher et al 2016) by Blinded Independent Radiology Committee (BIRC)
Expansion Stage: Overall Survival (OS)
For Cohort 10 (CRC): Overall Survival (OS) rate

Secondary Outcome Measures

Full Information

First Posted
December 15, 2021
Last Updated
October 2, 2023
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT05176483
Brief Title
Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors
Acronym
STELLAR-002
Official Title
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis

4. Oversight

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

5. Study Description

Brief Summary
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in subjects with advanced solid tumors. In the Expansion Stage, the safety and efficacy of XL092 as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Metastatic Castration-resistant Prostate Cancer, Urothelial Carcinoma, Solid Tumor, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose-escalation followed by expansion phase with parallel assignment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1078 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XL092 + Nivolumab Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Arm Title
XL092 + Nivolumab + Ipilimumab Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Arm Title
XL092 + Nivolumab Expansion Cohorts
Arm Type
Experimental
Arm Description
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Arm Title
XL092 + Nivolumab + Ipilimumab Expansion Cohorts
Arm Type
Experimental
Arm Description
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Arm Title
XL092 Single-Agent Expansion Cohorts
Arm Type
Experimental
Arm Title
XL092 + Nivolumab + Relatlimab Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Arm Title
XL092 + Nivolumab + Relatlimab Expansion Cohorts
Arm Type
Experimental
Arm Description
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Intervention Type
Drug
Intervention Name(s)
XL092
Intervention Description
XL092 orally once daily (qd)
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
360 mg IV infusion once every 3 weeks (q3w)
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
480 mg IV infusion once every 4 weeks (q4w)
Intervention Type
Drug
Intervention Name(s)
Nivolumab + Relatlimab
Intervention Description
IV administration of nivolumab + relatlimab
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs)
Description
To evaluate the safety of XL092 when administered alone or in combination therapy regimens through the evaluation of incidence and severity of AEs and SAEs, including imAEs
Time Frame
up to 36 months
Title
Expansion Stage: Objective Response Rate (ORR)
Description
To evaluate ORR in subjects with measurable disease as assessed by the Investigator per RECIST 1.1
Time Frame
up to 24 months
Title
Expansion Stage: Progression-Free Survival (PFS)
Description
For Cohort 3 (mCRPC): To evaluate duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria (Scher et al 2016) by Blinded Independent Radiology Committee (BIRC)
Time Frame
up to 24 months
Title
Expansion Stage: Overall Survival (OS)
Description
For Cohort 10 (CRC): Overall Survival (OS) rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic. Dose-Escalation Cohorts: Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Expansion Cohort 1 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy. Note: Prior non-VEGF targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose. Expansion Cohort 2 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component. Must have radiographically progressed after a combination therapy consisting of a PD-1/PD-L1 targeting mAb with a VEGFR-TKI or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy. Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma. Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate. Must have progressed during or after one NHT given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC. Expansion Cohort 4 (UC, ICI-naive): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra). Must have progressed during or after prior first-line platinum-based combination therapy, including subjects who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence < 12 months from the end of last therapy. Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease. Expansion Cohort 5 (UC, ICI-experienced): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra). Must have progressed during or after prior PD-1/PD-L1 targeting ICI therapy given as monotherapy, combination therapy, maintenance therapy or adjuvant therapy. Must have received no more than 2 prior lines of systemic anticancer therapy for unresectable advanced or metastatic disease. Expansion Cohort 6 (nccRCC): Subjects with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary RCC (any type), unclassified RCC, and translocation-associated. Among the eligible histologic subtypes, sarcomatoid features are allowed. No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose. Expansion Cohort 7 (HCC): Subjects with inoperable locally advanced, recurrent, or metastatic HCC that is not amenable to curative treatment or locoregional therapy. Expansion Cohort 8 (NSCLC): Subjects with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score [TPS] 1-49%) and without prior systemic anticancer therapy for metastatic disease. Expansion Cohort 9 (NSCLC): Subjects with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease. Expansion Cohort 10 (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum. Expansion Cohort 11 (HNSCC): Subject with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1. For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator. For expansion cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained. Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy. Karnofsky Performance Status (KPS) ≥ 70%. Adequate organ and marrow function. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception. Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: For all Dose-Escalation cohorts: Prior treatment with XL092. For all Expansion Cohorts: Prior treatment with XL092, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1/PD-L1, LAG-3 and CTLA-4 targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC). For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment. For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment. For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC): Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment. Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment. Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before first dose of study treatment. Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Administration of a live, attenuated vaccine within 30 days prior to enrollment. Uncontrolled, significant intercurrent or recent illness. Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Subjects with inadequately treated adrenal insufficiency. Pregnant or lactating females. Any other active malignancy within two years before first dose of study treatment, except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb. For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC. For Cohort 4 (UC, ICI-naïve): Subjects who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment. For Cohort 6 (nccRCC, 1L): Subjects with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC. For Cohort 7 (HCC): Documented hepatic encephalopathy (HE) within 6 months before randomization (see Section 6.5.2 for a case definition of HE). Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization. Subjects who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to randomization. Subjects with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and/or TAS-102. For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area. For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, MSS, 2L+), and 11 (HNSCC): Troponin T (TnT) or I (TnI) > 2 × institutional ULN. Note: Additional Inclusion and Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Exelixis Clinical Trials
Phone
1-888-EXELIXIS (888-393-5494)
Email
druginfo@exelixis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Backup or International
Phone
650-837-7400
Facility Information:
Facility Name
Exelixis Clinical Site #67
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #1
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #59
City
Solvang
State/Province
California
ZIP/Postal Code
93463
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #62
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #49
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #48
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #11
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #47
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #61
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Exelixis Clinical Site #8
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #26
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #4
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #14
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #7
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #65
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #13
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #68
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #2
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #5
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #55
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #60
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #6
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #12
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #10
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #51
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #32
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #24
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #9
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #3
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #46
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #70
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #50
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #66
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #33
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #16
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #35
City
Birtinya
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #42
City
Saint Leonards
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #36
City
Sydney
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #31
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #29
City
Wien
ZIP/Postal Code
1020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #39
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #37
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #64
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #63
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #72
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #52
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #71
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #69
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #38
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #40
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #30
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #45
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #20
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #34
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #28
City
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #54
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #23
City
Seville
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #18
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #41
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #53
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #15
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #27
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #17
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #57
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #43
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #58
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #19
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #56
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #25
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #21
City
Chur
State/Province
Graubunden
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #22
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #44
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

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