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Monoclonal Antibodies

Avelumab for Thymic Cancer

Phase 2

Recruiting

Led By Arun Rajan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have advanced, unresectable disease that is not amenable to surgical resection

Participants must have had at least one prior line of platinum-based chemotherapy or participant must have refused cytotoxic chemotherapy

Must not have

Participants with symptomatic brain metastases

Non-oncology vaccine therapies for prevention of infection disease within 4 weeks of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every other cycle

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if the drug avelumab is safe and well-tolerated, and is effective in treating relapsed or refractory thymoma and thymic carcinoma.

Who is the study for?

Adults over 18 with thymoma or thymic carcinoma that's worsened after platinum chemotherapy can join. They need at least one measurable tumor and good organ/marrow function. They must not be pregnant, agree to use effective contraception, and have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory).

What is being tested?

The trial is testing Avelumab's safety and effectiveness for those whose cancer has returned post-chemotherapy. Participants will receive Avelumab infusions every two weeks, possibly alongside pre-medications like Benadryl and Tylenol to reduce infusion reactions.

What are the potential side effects?

Avelumab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, possible blood abnormalities, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be treated with surgery.

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I have had platinum-based chemotherapy or refused it.

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My cancer is confirmed to be thymoma or thymic carcinoma.

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My organ and bone marrow functions are normal.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are causing symptoms.

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I haven't had vaccines for infection prevention within the last 4 weeks.

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I am legally unable to make my own decisions.

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I have had an organ or stem-cell transplant.

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I have a serious heart condition.

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I have tested positive for HIV or have AIDS.

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I am not taking any drugs that are not allowed in the study.

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I have an autoimmune disease that could worsen with immune-stimulating treatments.

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I still have side effects from previous cancer treatments.

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I do not have any active infections needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of death

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of death for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) based on RECIST 1.1 criteria

Safety and tolerability of Avelumab based on NCI-CTCAE v4.0

Secondary study objectives

Duration of Response

Immune-related progression-free survival (irPFS)

Overall Survival (OS)

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Endocrine disorders

Metabolism and nutrition disorders

Nervous system disorders

General disorders and administration site conditions

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1 AvelumabExperimental Treatment1 Intervention

Avelumab will be administered at a dose of 10 mg/kg intravenously once every two weeks until disease progression or development of intolerable adverse events.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

0 / 15Eligibility criteria met