Neoplasms

All Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Aggression

Thyroid Carcinoma, Anaplastic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Anaplastic Thyroid Cancer

Hurthle Cell Thyroid Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

Patients receive vudalimab IV over 1 hour on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Vudalimab

Study Coordinator

Jochen H. Lorch, M.D.

Maria E. Cabanillas, M.D.

Jochen H Lorch, M.D.

This phase II trial tests whether vudalimab works to shrink tumors in patients with anaplastic thyroid cancer or hurthle cell thyroid cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To evaluate the antineoplastic efficacy of vudalimab (XmAb2071) in anaplastic thyroid cancer, as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

SECONDARY OBJECTIVES:

I. To estimate progression-free survival (PFS) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

II. To estimate 16-week progression-free survival (PFS-16) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

III. To estimate overall survival (OS) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

IV. To determine the clinical benefit rate (CBR) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

V. To calculate the duration of response (DOR) in patients with anaplastic thyroid cancer who have responded to XmAb20717 therapy.

VI. To calculate the duration of clinical benefit (DoCB) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

VII. To assess the toxicity profile of XmAb20717 in patients with anaplastic thyroid cancer, according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:

I. To conduct correlative, translational research to identify markers associated with response to XmAb20717 (i.e., neo-epitopes) and to explore the immune microenvironment in patients with anaplastic thyroid cancer and Hurtle cell cancer.

II. To administer XmAb20717 to a small, exploratory cohort of patients with Hurtle cell thyroid cancer (HCC) to obtain pilot efficacy, safety, and correlative data for this population.

OUTLINE:

Patients receive vudalimab intravenously (IV) over 1 hour on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer

A Phase II, Multicenter Study of XmAb20717 in Patients With Metastatic Anaplastic Thyroid Cancer With an Exploratory Cohort in Aggressive Hurthle Cell Thyroid Cancer

Defined as the proportion of treated subjects in the Main Cohort (ATC) who experience an objective response. Objective response is defined as achieving a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmation of response should be conducted via imaging \>= 28 days after the response was first documented. The date of first response for either CR or PR will be used for the calculation of ORR.

Median PFS will be calculated based on the Kaplan-Meier estimates of PFS.

Will be calculated based on the Kaplan- Meier estimates of PFS as the proportion of evaluable subjects who are alive and progression-free at 16 weeks after registration.

Participants will be followed for overall survival for up to 5 years, or until withdrawal of consent, or death; whichever occurs first.

Defined as a RECIST 1.1 'best response' of confirmed 'complete response (CR),' or confirmed 'partial response (PR),' or 'stable disease (SD) for \>= 16 weeks' (calculated from the time of registration). For CR and PR, confirmation of response should be conducted via imaging \>= 28 days after the response was first documented.

Confirmation of response for CR or PR should be conducted via imaging \>= 28 days after the response was first documented. The date of first response for either CR or PR will be used as the starting point for the calculation of DOR. Disease progression is defined as 'progressive disease (PD)' per RECIST 1.1 (taking as reference for progressive disease the smallest tumor measurements recorded on study).

Confirmation of response (CR or PR) should be conducted via imaging \>= 28 days after the response was first documented. Disease progression is defined as 'progressive disease (PD)' per RECIST 1.1 (taking as reference for progressive disease the smallest tumor measurements recorded on study). If disease progression is not observed prior to initiating subsequent anti-cancer therapy, or prior to the end of the study follow-up period, or completion of study participation (whichever is sooner), the DoCB will be censored at the last date when the patient was known to be alive and progression-free.

Frequency of adverse events by type, severity (grade), timing, and attribution to vudalimab (XmAb2071), according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

National Cancer Institute (NCI)

Northwestern University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Docetaxel

Carboplatin

Olaparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Vudalimab IV, carboplatin IV, cabazitaxel IV

vudalimab + carboplatin + cabazitaxel

vudalimab + olaparib

vudalimab monotherapy

vudalimab + docetaxel

Vudalimab IV, cabazitaxel or docetaxel IV

vudalimab + cabazitaxel or docetaxel

Jolene Shorr

Ginger Lee

This Phase 2 study will investigate the safety and clinical activity of vudalimab (XmAb20717) alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior therapy.

Detailed Description:

This is a Phase 2, open-label, multiple-dose, multiple-arm, parallel assignment study in patients with mCRPC who have progressed on prior therapy. It will enroll subjects into 1 of 5 molecularly defined cohorts based on the results of acceptable, documented prior diagnostic testing:

* Cohort A: Aggressive variant prostate cancer (AVPCa)
* Cohort B: Homologous recombination deficient (HRD)/cyclin-dependent kinase 12 (CDK12) biallelic loss tumors that have progressed on poly-adenosine diphosphate ribose polymerase inhibitors (HRD/CDK12 PARP Progressors) - Closed to Enrollment
* Cohort C: HRD/CDK12 biallelic loss tumors, naive to PARP inhibitors (HRD/CDK12 PARP Naïve) - Closed to Enrollment
* Cohort D: Microsatellite instability-high (MSI-H) or mismatch repair deficient (MMRD), or tumor mutational burden-high (TMB-H) tumors - Closed to Enrollment
* Cohort E: No Targetable Mutations

XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapies in Selected Subjects With Metastatic Castration-Resistant Prostate Cancer

Xencor, Inc.

Immune System Diseases

Adenocarcinoma

Hypersensitivity

Patients receive vudalimab IV on days 1 and 15 plus abiraterone PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

Patients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

Patients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22 plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

Abiraterone

Undergo blood and stool sample collection

Biospecimen Collection

Bone Scan

Computed Tomography

Enzalutamide

FDG-Positron Emission Tomography

Magnetic Resonance Imaging

PSMA PET Scan

Bassel Nazha, MD, MPH

Wilena Session

This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive prostate cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to standard of care treatments may be effective in treating metastatic castration sensitive prostate cancer.

PRIMARY OBJECTIVE:

I. To determine the safety and tolerability of vudalimab (XmAb20717) in combination with standard of care treatment in subjects with metastatic castration sensitive prostate cancer (mCSPC) as assessed by frequency and intensity of adverse events.

SECONDARY OBJECTIVE:

I. To assess the preliminary antitumor activity of vudalimab (XmAb20717) with standard of care treatment.

TERTIARY/EXPLORATORY OBJECTIVE:

I. To identify factors that may be indicative of response to vudalimab (XmAb20717) in combination with standard of care treatments.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT A: Patients receive vudalimab intravenously (IV) on days 1 and 15 plus abiraterone orally (PO) once daily (QD) of 4-week cycles on study. Patients also undergo prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and fludeoxyglucose (FDG) PET scans during screening. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) scans, bone scans, and blood sample collection throughout the study.

COHORT B: Patients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

COHORT C: Patients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22 plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer

Multiple-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb20717 in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer

Will be assessed using the National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 5.0 where, Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living.

Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number.

Will be assessed per Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as outlined in Prostate Cancer Working Group 31 (soft tissue to be assessed by RECIST 1.1, and bone disease to be assessed by Prostate Cancer Working Group 3) by radiologic evaluation.

PSA response rate: PSA decline greater than or equal to 50% from baseline up to 24 weeks from treatment initiation.

Will be summarized with the 2-sided 95% CI using the Clopper-Pearson method. Kaplan-Meier methods will be used to estimate median survival time or time-specific survival rate with a 95% confidence interval for rPFS or a time-to-event outcome.

PSA decline \>= 50% and will be calculated along with 95% exact confidence intervals.

The fold change of the numbers of CD8 T-cells or other tumor-specific T-cells before and after treatment will be described by summary statistics (mean, median, Q1, Q3, standard deviation).

PSA undetectable rate will be assessed by PSA \< 0.2 ng/mL up to 24 weeks from treatment initiation. Will be estimated with the Kaplan-Meier method with time-specific rate estimated with 95%CI.

Will be assessed per PCWG-modified RECIST 1.1 and calculated along with 95% exact confidence intervals.

Emory University

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Pemetrexed

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous

Vudalimab + Carboplatin + Pemetrexed

Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous

Pembrolizumab + Carboplatin + Pemetrexed

Michael Chiarella

The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).

This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.

Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC

A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment

Progressive disease per RECIST 1.1 or death, whichever comes first

Objective response rate as determined by investigator, duration of response (Part 1 and Part 2)

Examine ctDNA changes as a surrogate marker for disease burden (Part 1 and Part 2)

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Endometrial Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Epithelial-myoepithelial Carcinoma

vudalimab

Patti McGovern

Jolene Shore, MD

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab (XmAb20717) in patients with selected advanced gynecologic and genitourinary malignancies.

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab in patients with selected advanced gynecologic and genitourinary malignancies and to identify tumor types for further evaluation.

In Stage 1, subjects will be enrolled into 1 of 5 tumor-specific, parallel cohorts (n = 10 each):

* Platinum-resistant high-grade serous ovarian cancer (HGSOC)
* Chemotherapy relapsed or refractory clear cell ovarian, endometrial, or peritoneal cancer
* Immune-checkpoint-inhibitor-refractory microsatellite stable (MSS) endometrial cancer (EC)
* Previously treated recurrent or metastatic cervical cancer
* High-risk metastatic castration-resistant prostate cancer (mCRPC)

Within each tumor-specific cohort in Stage 1, a primary endpoint of ORR at 12 weeks, based on investigator review, will be used to determine cohort expansion into Stage 2. Each Stage 1 cohort that achieves an ORR of ≥ 20% (at least 2 out of 10 subjects with an objective response) will enroll up to an additional 20 subjects in Stage 2. Cohorts with an ORR of less than 20% will discontinue enrollment. However, additional factors will be considered in determining an expansion into Stage 2 (eg, enrollment rate, complete versus partial response, and DOR).

A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies

A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and High-Risk Metastatic Castration-Resistant Prostate Cancer

To determine the Objective Response Rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer	NCT05453799	Locally Advance... Metastatic Thyr... Metastatic Thyr...	Vudalimab	18 Years -	Northwestern University
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer	NCT05005728	Metastatic Cast...	vudalimab + car... vudalimab + ola... vudalimab monot... vudalimab + doc... vudalimab + cab...	18 Years -	Xencor, Inc.
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer	NCT05733351	Castration-Sens... Metastatic Pros... Stage IVB Prost...	Abiraterone Biospecimen Col... Bone Scan Computed Tomogr... Docetaxel Enzalutamide FDG-Positron Em... Magnetic Resona... PSMA PET Scan Vudalimab	18 Years -	Emory University
Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer	NCT05453799	Locally Advance... Metastatic Thyr... Metastatic Thyr...	Vudalimab	18 Years -	Northwestern University
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC	NCT06173505	Nonsquamous Non...	Vudalimab + Car... Pembrolizumab +...	18 Years -	Xencor, Inc.
A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies	NCT05032040	Ovarian Cancer Clear Cell Carc... Endometrial Can... Cervical Carcin... Metastatic Cast...	vudalimab	18 Years -	Xencor, Inc.
A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies	NCT05032040	Ovarian Cancer Clear Cell Carc... Endometrial Can... Cervical Carcin... Metastatic Cast...	vudalimab	18 Years -	Xencor, Inc.
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer	NCT05005728	Metastatic Cast...	vudalimab + car... vudalimab + ola... vudalimab monot... vudalimab + doc... vudalimab + cab...	18 Years -	Xencor, Inc.

Spots Global Cancer Trial Database for vudalimab

Every month we try and update this database with for vudalimab 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 vudalimab

Every month we try and update this database with for vudalimab 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 vudalimab 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.