Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Subjects with mCRC will receive XL092 + atezolizumab

Subjects with mCRC will receive active comparator of regorafenib

Supplied as tablets; administered orally daily

XL092

Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w)

Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle

Regorafenib

Exelixis Clinical Trials

Backup or International

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Defined as the time randomization to the earlier of either radiographic progressive disease (PD) as assessed by the Investigator per RECIST 1.1 or death from any cause.

Defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per RECIST 1.1 criteria.

Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to either radiographic disease progression or death due to any cause.

The primary objective of this study is to evaluate OS of XL092 + atezolizumab versus regorafenib in non-liver metastases (NLM) subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy.

Subjects without liver metastases (NLM) are defined as subjects without active liver metastases at screening as determined on baseline imaging of the liver as performed by CT scan with contrast or MRI.

Definitively treated liver metastases (which includes surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy, but not yttrium-90 or chemoembolization alone) that were treated at least 6 months prior to enrollment with no evidence of radiologic progression on subsequent imaging are considered to be non-active liver metastases.

The key secondary objective is to evaluate OS of XL092 + atezolizumab versus regorafenib in all randomized subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy.

Exelixis

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lipid Regulating Agents

Hypoglycemic Agents

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Amino Acids

Gemcitabine

Docetaxel

Bevacizumab

Carboplatin

Pemetrexed

Sacituzumab govitecan

Immunomodulating Agents

Ipatasertib

Evolocumab

Linagliptin

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Incretins

Hormones

Hormone Antagonists

Dipeptidyl-Peptidase IV Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

PCSK9 Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Serine Proteinase Inhibitors

Immunoconjugates

Immunologic Factors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Serine

Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression.

Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.

Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.

Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.

Cobimetinib

Cycle 1:

RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage.

Subsequent cycles:

RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.

RO6958688

Docetaxel is administered by IV on Day 1 of each 21 day cycle.

CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.

CPI-444

Pemetrexed is administered by IV on Day 1 of a 21 day cycle.

Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.

Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.

Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.

Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.

Tocilizumab

Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.

Bevacizumab is administered by IV on Day 1 of each 21-day cycle.

Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.

Sacituzumab Govitecan

Radiation

Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.

Tiragolumab is administered on Day 1 of each 21 day cycle.

Tiragolumab

XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.

Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.

Camonsertib

Clinical Trials

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Hoffmann-La Roche

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Transitional Cell

Prostatic Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Carcinoma, Hepatocellular

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Nivolumab

Ipilimumab

Relatlimab

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.

360 mg IV infusion once every 3 weeks (q3w)

1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

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)

480 mg IV infusion once every 4 weeks (q4w)

IV administration of nivolumab + relatlimab

Nivolumab + Relatlimab

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.

Dose-escalation followed by expansion phase with parallel assignment.

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

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

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

To evaluate ORR in subjects with measurable disease as assessed by the Investigator per RECIST 1.1

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)

For Cohort 10 (CRC): Overall Survival (OS) rate

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Avelumab

Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.

The MTD or recommended dose from the dose-escalation stage may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mCRPC).

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

The MTD or recommended dose from the dose-escalation stage may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).

Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)

Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

single-agent and combination therapy dose-escalation followed by cohort-expansion

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

To determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with immune checkpoint inhibitors (ICIs) to subjects with advanced solid tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	NCT05425940	Colorectal Canc...	XL092 Atezolizumab Regorafenib	18 Years -	Exelixis
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)	NCT03337698	Carcinoma, Non-...	Atezolizumab Cobimetinib RO6958688 Docetaxel CPI-444 Pemetrexed Carboplatin Gemcitabine Linagliptin Tocilizumab Ipatasertib Bevacizumab Sacituzumab Gov... Radiation Evolocumab Tiragolumab XL092 Camonsertib	18 Years -	Hoffmann-La Roche
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	NCT05425940	Colorectal Canc...	XL092 Atezolizumab Regorafenib	18 Years -	Exelixis
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	NCT05425940	Colorectal Canc...	XL092 Atezolizumab Regorafenib	18 Years -	Exelixis
Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors	NCT05176483	Renal Cell Carc... Metastatic Cast... Urothelial Carc... Solid Tumor Hepatocellular ... Non-small Cell ... Colorectal Canc... Head and Neck S...	XL092 Nivolumab Ipilimumab Nivolumab Nivolumab Nivolumab + Rel...	18 Years -	Exelixis
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors	NCT03845166	Neoplasm Malign... Renal Cell Carc... Hormone Recepto... Metastatic Cast... Colorectal Canc...	XL092 Atezolizumab Avelumab	18 Years -	Exelixis
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma	NCT05678673	Non-Clear Cell ...	XL092 Nivolumab Sunitinib Malat...	18 Years -	Exelixis

Spots Global Cancer Trial Database for xl092

Every month we try and update this database with for xl092 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xl092

Every month we try and update this database with for xl092 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xl092 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.