Trials on Bones and soft tissue

INFORM RegistryRecruiting

INFORM Registry Study on Individualized Treatment for Patients with Recurrent Malignant Disease, with a Special Focus on Children and Adolescents

Many types of cancer can now be cured using modern treatment options. Nevertheless, relapses and progressive cancer remain a major challenge. The goal of the INFORM-REGISTER study is to use molecular genetic testing methods to gather information about tumor characteristics that can be used by treating physicians to inform future treatment decisions. Patients aged 0 to 40 with previously treated, treatment-resistant, or progressive cancer who no longer have any established curative treatment options available are eligible to participate in the study.

0–40 years · Relapsed / refractory · Phase IV

COSS-RegisterRecruiting

A prospective observational study on the disease course in children, adolescents, and adults with osteosarcomas and biologically related bone sarcomas

Osteosarcomas are rare malignant bone tumors whose biological behavior is not yet fully understood. Because the disease is very rare, it is difficult to collect sufficient data on its course and treatment options. The goal of the COSS Registry is to systematically collect various data on these diseases throughout Germany. This will help generate new scientific information and insights into the disease, its prevalence, its course, and its prognosis. All patients with osteosarcoma or a biologically related bone sarcoma treated in Germany are eligible to participate in this study.

0 years and older · First line · Phase IV

INFORM2 NivEntRecruiting

A single-arm study of the treatment of high-risk tumors with nivolumab and entinostat in children and adolescents

So-called high-risk tumors often progress very rapidly despite optimal treatment and are usually resistant to standard therapies. Immunotherapies and targeted drugs, such as the study drugs nivolumab and entinostat, offer new hope. Previous studies suggest that this combination may inhibit tumor growth in tumors with specific genetic characteristics. The goal of the INFORM2 study is to to investigate the efficacy of the combination therapy of nivolumab and entinostat in children and adolescents with treatment-resistant or recurrent high-risk tumors, and to compare whether the efficacy of this combination therapy differs in tumors with specific genetic alterations compared to those without these characteristics. Patients between the ages of 2 and 21 with a brain tumor or solid tumor classified as high-risk are eligible to participate. The tumor must either have a myc(n) amplification, a high mutation burden, or high PD-L1 expression—or none of these characteristics.

2–21 years · Relapsed / refractory · Phase I/II

IMA401-101Recruiting

Study to Evaluate the Safety, Tolerability, and Efficacy of a New Drug (Name: IMA401) in Patients with Recurrent or Uncontrolled Breast Cancer

Solid tumors are cancers that develop in organs such as the lungs, liver, or breast. When these tumors progress and no longer respond to standard therapies, novel drugs may be considered as additional treatment options. The goal of the IMA401-TCER study is to investigate the safety and tolerability of the new drug IMA401, which specifically targets certain cancer cells. Eligible participants include women and men aged 18 and older with advanced or metastatic solid tumors, including breast cancer, that no longer respond to standard therapies and exhibit a specific genetic profile (HLA-positive and MAGEA4/8).

18 years and older · Relapsed / refractory · Phase I

INCB-84344-102

Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Pediatric Leukemias, Lymphomas, or Solid Tumors

When malignant diseases of the blood system (leukemias, lymphomas) or tumors of other organs/tissues (solid tumors) in childhood do not respond to standard therapy (refractory) or recur (relapse), there are often significantly fewer established treatment regimens than in adults. Ponatinib, a tyrosine kinase inhibitor (TKI), is already approved for use in adults for certain forms of leukemia. The aim of this study is to investigate the safety and efficacy of ponatinib in children and adolescents with various types of cancer and to determine the optimal dose for treatment. Patients between the ages of 1 and 17 with previously treated, relapsed, or refractory leukemias, lymphomas, or solid tumors are eligible to participate.

1–17 years · Relapsed / refractory · Phase I/II

PYNNACLERecruiting

PYNNACLE Trial with Rezatapopt (PC14586): A New Treatment for Advanced Tumors with the TP53 Y220C Mutation

Rezatapopt is a novel, as-yet-unapproved drug that was developed specifically for the Y220C mutation in the TP53 gene. This gene controls cell growth; when a mutation occurs, the p53 protein loses its protective function, allowing cancer cells to multiply uncontrollably. Rezatapopt is intended to restore the function of the p53 protein. The PYNNACLE study is intended for patients with advanced solid tumors who have this specific genetic alteration (TP53 Y220C mutation). The goal of the study is to investigate the safety and efficacy of the investigational drug Rezatapopt. Eligible participants include women and men aged 18 and older, and, under certain conditions, adolescents between the ages of 12 and 17. The tumors must carry the TP53 Y220C mutation and must have already been treated with at least one prior cancer therapy.

12 years and older · Relapsed / refractory · Phase I/II

STARTActive, not recruiting

A Study of the Safety and Efficacy of PeptiCRAd-1, a Novel Immunotherapy, in the Treatment of Advanced and/or Metastatic Triple-Negative Breast Cancer

Treatment options for advanced-stage breast cancer have been limited to date. One new approach is the drug PeptiCRAd-1. These are genetically modified viruses that specifically target and destroy cancer cells while simultaneously activating the body’s own immune system to fight the tumor. The goal of the START study is to evaluate the safety and efficacy of PeptiCRAd-1 in combination with pembrolizumab—which is already approved—when standard therapy is no longer effective. Women and men aged 18 and older with certain solid tumors at the locally advanced or metastatic stage are eligible to participate in the study; in the case of breast cancer, neither hormone receptors nor HER-2 receptors may be detectable (triple-negative).

18 years and older · Relapsed / refractory · Phase I

iEuroEwingRecruiting

International Study on Optimizing Treatment for Patients with Ewing Sarcoma

Ewing sarcomas are currently treated with a combination of chemotherapy, surgery, and radiation therapy. It remains unclear whether chemotherapy as adjuvant therapy could improve survival. It is also unclear whether a higher radiation dose in patients with localized disease leads to longer survival without causing excessive side effects. The goal of the iEuroEwing study is to compare different radiation doses for efficacy and safety in patients with localized disease and to evaluate the effect of adjuvant therapy with the drugs vinorelbine and cyclophosphamide. Women and men between the ages of 2 and 49 with Ewing sarcoma are eligible to participate in the study.

2–50 years · First line · Phase III

BZKF-Register zu metastasierten WeichteilsarkomenRecruiting

Long-term observational study on the disease course of patients with newly diagnosed metastatic soft tissue sarcoma

The treatment of metastatic soft tissue sarcoma poses a challenge. Therefore, long-term data on the various therapeutic approaches for this rare disease are needed. The goal of the Metastatic Soft Tissue Sarcoma Registry is to monitor and systematically record the course of the disease in patients over an extended period of time in order to identify prognostic clinical factors for treatment. Eligible participants include women and men aged 18 and older who have been diagnosed with soft tissue sarcoma with newly diagnosed distant metastases.

18 years and older · First line

FaR-RMSRecruiting

Personalized Treatment of Rhabdomyosarcomas: A Comparison of New Drugs, Radiation Therapies, and Maintenance Strategies

Rhabdomyosarcomas (RMS) are classified as malignant soft tissue tumors, a group of rare cancers that primarily affect children and adolescents. Despite intensive treatment with chemotherapy, surgery, and radiation therapy, the prognosis remains poor, especially for patients at high risk of relapse or those with metastatic disease. Therefore, new treatment approaches are needed that are both more effective and better tolerated. The goal of the FaR-RMS study is to improve individualized treatment for rhabdomyosarcoma; to this end, many treatment modalities are being investigated and compared. The study aims to evaluate the effects of new drug combinations, investigate whether changing the duration of maintenance therapy affects the risk of relapse, and assess whether changes in the dose, extent (in cases of metastatic disease), and timing of radiation therapy can improve outcomes and quality of life. Patients with newly diagnosed or recurrent rhabdomyosarcoma (except pleomorphic RMS) are eligible to participate. Depending on the course of the disease and risk group, patients may be enrolled in multiple study groups over the course of the trial, for example, for different treatment phases. There are specific eligibility criteria and age limits for the various study groups.

0 years and older · Phase I/II

Trials on Bones and soft tissue11