Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Small Cell Lung Cancer

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Part A, will enroll participants with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort.

Part B, will enroll participants with advanced MCC not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents, consists of safety run-in cohorts followed by an expansion cohort.

Part C will enroll participants with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort.

XmAb18087

XmAb18087 ± Pembrolizumab

Benjamin Thompson, MD, PhD

This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

This study was terminated by the sponsor. No participants enrolled in Part B.

Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer

A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol

A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a participant treated with study drug. The TEAE does not necessarily have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs may include the onset of new illness and the exacerbation of preexisting conditions. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."

ICON plc

Xencor, Inc.

Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.

Part A: XmAb18087 Monotherapy

Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.

Part C: XmAb18087 Monotherapy

Total

Age, Categorical

Sex: Female, Male

No data is reported here to maintain participant confidentiality.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All participants who received at least 1 dose of XmAb18087.

Study was terminated by the sponsor and only 2 participants each were enrolled in Parts A and C. No participants were enrolled for Part B. Data were not collected for the prespecified analyses of efficacy, pharmacokinetics, and immunogenicity outcome measures.

All participants who received at least 1 dose of XmAb18087. No participants were enrolled for Part B, therefore, only Parts A and C results are reported.

Number of Participants With Treatment-emergent Adverse Events

Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.

Overall Response Rate as Assessed by RECIST 1.1 Criteria

Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria

Duration of Response

Progression-free Survival as Assessed by Per RECIST 1.1 Criteria

Data was not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.

Overall Survival as Assessed by Per RECIST 1.1 Criteria

Participants administered XmAb18087 Monotherapy.

XmAb18087 Monotherapy

Analysis was not performed as data were not collected for this outcome measure due to early study termination. No participants were enrolled for Part B.

Pharmacokinetics: Maximum Observed Serum Concentration

Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Immunomodulating Agents

Spartalizumab

Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

100 mg lyophilisate in vial received 400 mg every 4 weeks

spartalizumab (PDR001)

120 mg once daily first 21 days of each 28-day cycle (=4 weeks)

regorafenib

Novartis Pharmaceuticals

This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.

Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.

Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.

Severity including dose interruptions and reductions.

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Microsatellite Instability

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Basal Cell

Mesothelioma

Mesothelioma, Malignant

Skin Neoplasms

Melanoma, Cutaneous Malignant

Fallopian Tube Neoplasms

Endometrial Neoplasms

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Kidney Neoplasms

Kidney Diseases

Head and Neck Neoplasms

Breast Diseases

Adenoma

Neoplasms, Mesothelial

Fallopian Tube Diseases

Neoplasms, Basal Cell

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Malignant Mesothelioma

Acral Lentiginous Melanoma

Analgesics

Interleukin-2

Analgesics, Non-Narcotic

MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion

MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).

MDNA11

MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).

Nina Merchant

Melissa Coello

Martin Bexon, MBBS

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.

The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in multiple parts:

* Monotherapy (MDNA11 alone) dose escalation
* Monotherapy (MDNA11 alone) dose expansion in select tumor types
* Combination (MDNA11 + pembrolizumab) dose escalation
* Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types

Approximately 115 patients will be enrolled.

After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met. Patients can withdraw from participation at any time.

Sequential dose escalation (MDNA11 monotherapy and MDNA11 + pembrolizumab) followed by dose expansion with MDNA11 monotherapy and combination (MDNA11 + pembrolizumab).

Male Female (Women of Childbearing Potential will be subject to pregnancy testing)

A Beta-only IL-2 ImmunoTherapY Study

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Measured by change in Tumor Infiltrating Lymphocyte (TIL) levels

Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

Rate of TRAEs in patients with advanced solid tumors

Rate of TEAEs in patients with advanced solid tumors

Maximum observed serum drug concentration

Time to maximum observed serum drug concentration

Area under the serum concentration vs time curve from time zero to the last measurable concentration

Incidence and persistence of anti-drug antibodies to MDNA11

Measurement of translational parameters - Flow cytometry analysis of immune cells in blood and serum measurements of cytokine levels

Assessed by RECIST v1.1 and iRECIST; CR+PR/Evaluable N

Time from signing ICF to disease progression

Merck Sharp & Dohme LLC

Medicenna Therapeutics, Inc.

Glucopyranosyl Lipid A in Stable Emulsion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer	NCT03081494	Metastatic Colo...	spartalizumab (... regorafenib	18 Years -	Novartis
A Beta-only IL-2 ImmunoTherapY Study	NCT05086692	Advanced Solid ... Unresectable So... Clear Cell Rena... Triple Negative... Non-Small Cell ... Non-Small Cell ... Colorectal Canc... Gastric Cancer Cervical Cancer Basal Cell Carc... Bladder Cancer Merkel Cell Car... Squamous Cell C... Cutaneous Squam... Pleural Mesothe... Esophageal Canc... Endometrial Car... Solid Tumor Solid Tumor, Ad... MSI-H Solid Mal... Cancer With A H... Epithelial Ovar... Primary Periton... Gastroesophagea... Acral Melanoma Mucosal Melanom... Cutaneous Melan... DMMR Solid Mali... Fallopian Tube ... Ovarian Cancer MSI-H Cancer DMMR Cancer Pancreas Adenoc... Skin Cancer	MDNA11 Pembrolizumab	18 Years -	Medicenna Therapeutics, Inc.
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma	NCT02035657	Merkel Cell Car...	GLA-SE	18 Years - 80 Years	Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer	NCT04916002	Merkel Cell Car... Cutaneous Squam... Basal Cell Carc... Triple Negative... Non-Small Cell ... Oropharynx Squa...	vidutolimod cemiplimab	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for mcc

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

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