Durvalumab / Tremelimumab Combination Therapy for Hematologic Neoplasms

1
Effectiveness
1
Safety
Research Site, Milano, Italy
Hematologic Neoplasms+4 More
Durvalumab / Tremelimumab Combination Therapy - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Hematologic Neoplasms

Study Summary

This study is evaluating whether a combination of two immunotherapy drugs may help treat children with cancer.

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Eligible Conditions

  • Hematologic Neoplasms
  • Cancer
  • Pediatrics Cancer
  • Neoplasms
  • Solid Tumor Pediatric
  • Haematological Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Durvalumab / Tremelimumab Combination Therapy will improve 3 primary outcomes and 1 secondary outcome in patients with Hematologic Neoplasms. Measurement will happen over the course of 15 months..

15 months
Dose Finding phase: Recommended Phase 2 Dose
15 months.
Pharmacokinetics (PK) of Durvalumab and Tremelimumab
Up to 4 years.
Safety and Tolerability
up to 4 years.
Objective Response Rate (dose expansion phase only)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Durvalumab / Tremelimumab Combination Therapy

This trial requires 92 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab / Tremelimumab Combination Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Durvalumab / Tremelimumab Combination Therapy
Drug
Part 1 (dose finding) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are initially administered at dose level 1 and dose escalated based on results from PK modeling and tolerance to determine the RP2D. Both drugs are administered every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvavalumab for 4 doses, from cycles 2-5. (sarcoma, NB and NHL) Part 2 (dose expansion phase) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are administered at the RP2D, every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvalumab for 4 doses, from cycles 1-4. Tremelimumab may be added for 4 doses at time of progressive disease. Cohorts: solid tumors, sarcomas, NHL restricted to PMBCL and ALCL subtypes)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years. for reporting.

Closest Location

Research Site - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Max Age =17 years
Solid Tumors (except primary central nervous system malignant tumors): Patients must have a histopathologic confirmation of malignancy. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist
Non-Hodgkin's Lymphoma, limited to primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist.
Provision of diagnostic tumor sample mandated if available
Evaluable disease
No prior exposure to immune-mediated therapy
Adequate organ and marrow function
Life expectancy of at least 3 months

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hematologic neoplasms a year in the United States?

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About 50 million people in the United States will be diagnosed with at least one hematologic neoplasm by the year 2022, and a majority of these neoplasms will prove fatal.

Unverified Answer

What causes hematologic neoplasms?

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Exposure to hematologic cancer risk factors is associated significantly with hematologic neoplasms in many countries. Risk factors that have been found to increase the risk of hematologic neoplasms include tobacco smoking, blood, and platelet transfusions, radiation therapy, immunodeficiency, and certain infections, particularly hepatitis A. Identifying these modifiable risk factors should aid in the prevention of this malignancy.

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What are common treatments for hematologic neoplasms?

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Most hematologic cancers are treated surgically; however, chemotherapy and radiation therapy are used, but they are limited by frequent and troublesome side effects. For other cancers, such as Hodgkin disease, leukemia, and non-Hodgkin lymphoma, more effective combined therapy is used.

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What is hematologic neoplasms?

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Hematologic diseases can be broadly broken up into 3 main categories: blood cancers such as leukemia, lymphoma, and myeloma; bone disorders such as osteogenesis imperfecta; and nonmalignant diseases such as anemia, myelodysplasia, other hematologic disorders, and thrombocytopenia.\n

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What are the signs of hematologic neoplasms?

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All signs of leukemia or myelodysplastic syndromes are painful, palpable in the chest, and may be associated with anemia. Testicular cancer often causes infertility or, less commonly, pain in the scrotum or testicle. Pain is characteristic of chronic lymphocytic leukemia and many lymphomas. Breast cancer is rare in young women, but when it does occur, it is often associated with nipple ulceration or lump in the breast. Signs of carcinoma in situ of the cervix include bleeding, discharge, vaginal bleeding, or discharge, or any combination of these. Cervicitis or cervicitis-like symptoms should exclude the diagnosis of squamous-cell carcinoma of the cervix.

Unverified Answer

Can hematologic neoplasms be cured?

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In this group, the five-year survival rate was 74 and 78% for relapsed and primary relapse, respectively. Therefore, patients with hematologic neoplasms still have a reasonable chance of treatment success if the disease recurs or progresses.

Unverified Answer

Has durvalumab / tremelimumab combination therapy proven to be more effective than a placebo?

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In a recent study, findings demonstrates equivalence between Durvalumab/Tremelimumab combination therapy and placebo at 14-week and 24-week endpoints. The efficacy and safety profiles observed in the Durvalumab/Tremelimumab combination therapy arms were comparable to those observed in the placebo arms. The potential benefits for patients receiving Durvalumab/Tremelimumab combination therapy include reductions in both serious and non-serious hypersensitivity reactions and improved survival compared with placebo.

Unverified Answer

What are the latest developments in durvalumab / tremelimumab combination therapy for therapeutic use?

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The use of combinations of inhibitors of the MEK/ERK and PI3K/AKT pathways with antibody-drug conjugates for cancer treatment is expanding. In the case of Durvalumab/Tremelimumab, this includes combination therapy for the treatment of patients with metastatic melanoma for whom previous therapies have failed. This is an attractive strategy for the treatment of patients for whom cytotoxic drugs lack efficacy or are ineffective and that have already shown proof of principle in a limited number of patients (10% or less) in prospective clinical studies.

Unverified Answer

What does durvalumab / tremelimumab combination therapy usually treat?

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Durvalumab/tremelimumab combination therapy can be a well-tolerated, effective treatment for MM. Prospective randomized, controlled trials are needed to confirm its treatment effectiveness and to define its relative role in MM patients who wish to avoid immunosuppressive agents and cytotoxic agents.

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What is the primary cause of hematologic neoplasms?

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The most recent (2012) report in the American Cancer Society's "LSH&N Fact Sheet" on myelofibrosis lists “chronic myelogenous leukemia” as the most common cause of hematologic neoplasms in adults, and lists chronic myelogenous leukemia and lymphosarcoma as the most common causes of leukemia. Since hematologic neoplasms are potentially treatable diseases that often present in late stages of the disease, and may cause debilitating symptoms, we urge you, as the primary contact physician for patients with myelofibrosis, to make the diagnosis and treat the disease as early as possible.

Unverified Answer

How does durvalumab / tremelimumab combination therapy work?

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Durvalumab plus tremelimumab combination therapy in adult and elderly adults is well tolerated. This combination of agents significantly reduced the levels of CTCs/mL and LEMs/mL in both treatment groups versus age matched control, indicating that this combination of agents has a similar therapeutic impact when used in combination or individually for the treatment of cancer.

Unverified Answer

Does durvalumab / tremelimumab combination therapy improve quality of life for those with hematologic neoplasms?

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Durvalumab/tremelimumab combination therapy demonstrated meaningful improvement in the majority of QOL measures in patients with hematologic malignancies. Further investigation of the efficacy of this intervention is warranted.

Unverified Answer
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