Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Infections

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

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

Carcinoma, Merkel Cell

Fallopian Tube Neoplasms

Endometrial Neoplasms

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 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

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Malignant Mesothelioma

Merkel Cell Carcinoma

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Interleukin-2

Antineoplastic Agents, Immunological

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.

Turcot Syndrome

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients will initially receive monotherapy PD1/PDL1 monoclonal antibody therapy.

Patients will initially receive dual blockade of both PD1/PDL1 and CTLA4

Patients will initially receive PD1/PDL1 monoclonal antibody combined with chemotherapy or targeted therapy.

Patients will receive other standard treatments for this tumor other than ICIs.

zhenghang Wang

Zhenghang Wang

Fengbin Zhang

Zhiwei Chang

Qiwei Wang

Zimin Liu

Hongxia Lu

Xuan Jin

Dong Yan

Xiaodong Wang

Ting Deng

This study is a multi-center, non-interventional, prospective clinical observational study, aiming to evaluate the effectiveness and safety of subsequent treatment in dMMR/MSI solid tumor patients who have never received ICIs under real-world conditions. Particular attention is paid to the efficacy in populations where treatment plans are adjusted based on ctDNA, and potential predictive or prognostic biomarkers are explored.

This study plans to enroll patients in the following four cohorts:

* Cohort A: Initially only receiving PD1/PDL1 monotherapy;
* Cohort B: Initially receiving simultaneous blockade of PD1/PDL1 and CTLA4;
* Cohort C: Initially receiving PD1/PDL1 monotherapy combined with chemotherapy or targeted therapy;
* Cohort D: Initially not using ICIs, receiving other standard treatments for this tumor type

To explore the role of ctDNA testing in therapeutic decision-making, patients with the first evaluation of SD in cohort A are divided into two groups: ctDNA testing/intervention group (Group A1) and ctDNA testing/non-intervention group (Group A2). In group A1, if there is no early response to ctDNA, the researchers and the patient will decide to add CTLA4 antibody or other potentially effective treatments after thorough communication. If there is an early response to ctDNA, then continue with PD1/PDL1 monoclonal antibody treatment. Patients in group A2 undergo ctDNA testing, but still continue with PD1/PDL1 monoclonal antibody treatment according to the RECIST v1.1 standard when the first evaluation of SD is made. Meanwhile, explore the role of 1-year ctDNA-MRD in guiding treatment in patients with long-term tumor control, and explore the guiding role of re-biopsy of tumor tissue or ctDNA testing in helping making treatment regimen after progression on ICIs.

Number of Subjects:

• This study will recruit patients nationwide for data collection over a period of 3 years. The plan is to enroll 100 cases in Cohort A, including 25 cases in Group A1 and 25 cases in Group A2; 30 cases in Cohort B; 30 cases in Cohort C; and 30 cases in Cohort D.

1. Blood sample collection: Collect 10mL of peripheral blood in a purple EDTA-K2 anticoagulant blood collection tube. If the blood plasma cannot be separated within the specified time, a Streck (EDTA-K3) blood collection tube can be used, and the patient's name, sample type, and collection time should be marked on the tube wall.
2. Plasma Separation: Whole blood samples are centrifuged at 4°C or room temperature, at 1800g for 10 minutes. Except for 0.5mL of whole blood reserved, all the whole blood is separated into plasma as much as possible. After centrifugation, carefully collect the upper layer of plasma into a new, labeled 5mL low-adsorption centrifuge tube, and finally seal with a sealing film for future use.

Registry Study in MSI/dMMR Solid Tumors

Multi-center, Non-interventional, Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability

Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.

Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation.

Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation.

Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0.

Peking University Cancer Hospital & Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.
Registry Study in MSI/dMMR Solid Tumors	NCT06004713	DMMR Cancer MSI-H Solid Tumor		18 Years -	Peking University Cancer Hospital & Institute

Spots Global Cancer Trial Database for dmmr cancer

Every month we try and update this database with for dmmr cancer 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 dmmr cancer

Every month we try and update this database with for dmmr cancer 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 dmmr cancer 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.