Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Docetaxel

Prednisone

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months).

Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)

Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4

lorigerlimab

Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer

docetaxel

A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer

Global Trial Manager

Alvaro Ocampo

Hatem Hassanein

Daniel Fein

Xiao Wei

Ralph Hauke, MD, FACP

Sumit Subudhi

Joseph Call, MD

William Skelton

Shahneen Sandhu

Jean Pascal Machiels

Sylvie Rottey

Frédéric Forget

Brieuc Sautois

Bonka Popova

Antoaneta Tomova

Bozhil Robev

Guilhem Roubaud

Eric Voog

Delphine Borchiellini

Mostefa Bennamoun

Friederike Schlurmann

Xavier Artignan

Carole Helissey

Raffaele Ratta

Alice Bernard Tessier

Tamta Makharadze

David Kochiashvili

Giorgi Adeishvili

Archil Chkhotua

Guram Karazanashvili

Tamar Melkadze

Amiran Matitashvili

Bogusława Karaszewska

Bożena Cybulska-Stopa

Cezary Szczylik

Jakub Żołnierek

Piotr Radziszewski

Iwona Skoneczna

Josselyn Molina-Avila

Begoña Mellado

Alejo Rodríguez-Vida

Enrique Gallardo

Jose Maroto

Elena Castro

Santiago Cabezas-Camarero

Begona Pérez Valderrama

Maria Jose Juan Fita

Mark Tuthill

Naveed Sarwar

Johann de Bono

Emma Gray

Denise Casey, M.D.

The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm).

Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.

A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.

ORR is defined as the number of participants who have a best overall response of confirmed complete response (CR) or partial response (PR) without prior confirmed bone progression

DoR is the time from the date of initial tumor response (CR or PR) to the date of first disease progression or death from any cause, whichever occurs first.

TTR is defined as the time from the start of treatment to the first objective response (CR or PR).

PSA50 response is defined as a ≥ 50% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 50%.

PSA90 response is defined as a ≥ 90% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 90%.

Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression.

Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression.

OS is defined as the time from the date of randomization to the date of death from any cause.

Time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE from any cause.

Time to pain progression is defined as the time interval from randomization to the first date a participant experiences pain progression. Higher scores indicate more severe pain.

The BPI-sf pain severity score consists of 4 items that assess pain at its worst, least, average, and current pain intensity. The pain severity score is the average of the 4 item scores. Higher scores indicate more severe pain.

The BPI-sf pain interference score includes 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The pain interference score is the average of the 7 interference items. Higher scores indicate more interference from pain in daily life.

The FACT-P consists of 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G) that measure physical, social/family, emotional, and functional well-being and 12 items that compose the Prostate Cancer Subscale (PCS). Higher scores indicate greater impact of prostate cancer on daily life.

Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

The highest measured concentration of lorigerlimab in the bloodstream.

AUC is the total amount of lorigerlimab in bloodstream after drug administration

Trough concentration is the concentration measured before a subsequent dose of lorigerlimab

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time

The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.

Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%

MacroGenics

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Carcinoma, Small Cell

Lung Neoplasms

Anus Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Small Cell Lung Cancer

Oral Squamous Cell Carcinoma

Anal Cancer

Neuroendocrine Tumor

Neuroepithelioma

vobramitamab duocarmazine 2.0 mg (Arm A)

vobramitamab duocarmazine 2.7 mg (Arm B)

vobramitamab duocarmazine

Ashley Ward, M.D.

Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents.

This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1.

Part 2 of the study will enroll participants with locally advanced or metastatic squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2.

In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first. Three arms will be compared: Arm A, Arm B, and control.

The ORR is defined as the percentage of participants in the response evaluable poplaiton who achieve a best overall response of conplete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.

The number of participants experiencing a complete response (CR) or partial response (PR) to treatment.

The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.

PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.

In participants with a decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later.

In participants with no decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.

Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.

Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.

An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.

The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.

PFS is defined as the time from the date of the first dose to the date of first PD per RECIST 1.1 criteria or death from any cause, whichever occurs first.

Neoplasm Metastasis

Pain

Neoplastic Processes

Radium Ra 223 dichloride

Male patients with a diagnosis of CRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223 has been made by the attending physician according to his/her medical practice.

Dosage and treatment duration according to the decision of the treating physician

Radium-223 dichloride, (Xofigo, BAY88-8223)

Bayer Study Director

This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.

Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases

PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers

Determined by the worst pain item on the Brief Pain Inventory - Short Form (BPI-SF) patient questionnaire. A clinically meaningful pain response is defined as an improvement of two points from the baseline BPI-SF worst pain score at any post-baseline assessment.

Determined by evaluating the worst pain item as well as the subscale scores for pain severity and pain interference as determined by patient responses on the BPI-SF questionnaire.

As determined by patient responses on the bone pain specific Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain (FACT-BP) questionnaire

As determined by the worst pain item on the BPI-SF patient questionnaire. Pain control is defined as no increase by two points from the baseline BPI-SF worst pain score.

As determined by the worst pain item on the BPI-SF patient questionnaire. Pain progression is defined as an increase by two points from the baseline BPI-SF worst pain score at any post baseline assessment.

Defined as the time between the first injection of Radium-223 until an increase in the BPI-SF worst pain item by at least two points

The following covariates will be analyzed: opioid use, assessment of extent of bone metastases, location of bone metastases,level of alkaline phosphatase at baseline, PSA (Prostate Specific Antigen) level at baseline, WHO pain score at baseline, pretreatment with chemotherapy (yes/no), pretreatment with deep androgen ablation by treatment with abiraterone or enzalutamide (yes/no), extent of bone uptake in known lesions, BSI

Only in patients with bone scan prior to start of treatment and a second scan during or within 6 weeks after end of Radium-223 treatment

Defined as the time from the first application of Radium-223 until start of next mCRPC treatment including e.g. chemotherapy and/or hormonal treatment

Defined as the time between the first injection of Radium-223 until the occurrence of first SSE defined as the first use of external beam radiation therapy to relieve skeletal symptoms, new symptomatic pathological vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention

Defined as the time interval from the start of Radium-223 therapy to death, due to any cause. Patients alive at the end of the study will be censored at the last date known to be alive.

Evaluated by comparing BSI values before and after Radium-223 treatment as well as by investigating the association of BSI with other outcome parameters like OS

Exploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)

Time from verified castration resistance to first injection of Radium-223

Description of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.

(e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer	NCT05848011	Androgen-Indepe... Androgen-Indepe... Prostate Cancer... Androgen-Insens... Androgen-Resist... Hormone Refract... Immunotherapy Immune Checkpoi... Inhibitory Chec...	lorigerlimab docetaxel Prednisone	18 Years -	MacroGenics
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors	NCT05551117	Castration-Resi... Androgen-Indepe... Androgen-Insens... Androgen-Resist... Hormone Refract... Anal Cancer Anal Neoplasm Carcinoma, Squa... Head and Neck S... Laryngeal Squam... Oral Squamous C... Malignant Melan... Melanoma Non-small Cell ... Non-small Cell ... Small-cell Lung... Small Cell Carc...	vobramitamab du... vobramitamab du... vobramitamab du...	18 Years -	MacroGenics
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases	NCT02398526	Castration-Resi...	Radium-223 dich...	18 Years -	Bayer
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer	NCT01171729	Prostatic Cance...	Autologous dend...	18 Years -	Samsung Medical Center
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors	NCT05551117	Castration-Resi... Androgen-Indepe... Androgen-Insens... Androgen-Resist... Hormone Refract... Anal Cancer Anal Neoplasm Carcinoma, Squa... Head and Neck S... Laryngeal Squam... Oral Squamous C... Malignant Melan... Melanoma Non-small Cell ... Non-small Cell ... Small-cell Lung... Small Cell Carc...	vobramitamab du... vobramitamab du... vobramitamab du...	18 Years -	MacroGenics
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases	NCT02398526	Castration-Resi...	Radium-223 dich...	18 Years -	Bayer
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer	NCT01171729	Prostatic Cance...	Autologous dend...	18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for hormone refractory prostatic cancer