What side effects are associated with this type of intervention?

Common treatments for ovarian cancer involving immune modulation, such as pembrolizumab, can lead to a range of side effects. These include fatigue, nausea, and immune-related adverse events like skin reactions, endocrine disorders, and pneumonitis. Specific to pembrolizumab, side effects can also include diarrhea, infusion-related reactions, and in some cases, severe immune-mediated conditions requiring corticosteroid treatment. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. While specific IL-2 pathway modulators like TransCon IL-2 β/γ are still under investigation, other immune-modulating treatments such as pembrolizumab, a PD-1 inhibitor, have been approved for use in certain cases of ovarian cancer. Additionally, PARP inhibitors like olaparib, niraparib, and rucaparib are approved for patients with BRCA mutations or other homologous recombination deficiencies. Bevacizumab, an anti-VEGF antibody, is also approved for use in combination with chemotherapy for advanced ovarian cancer.

What other types of research exist?

Promising novel alternatives to TransCon IL-2 β/γ for ovarian cancer patients include: 1) Pembrolizumab, a PD-1 inhibitor, which has shown efficacy in various cancers including ovarian cancer. 2) Nivolumab combined with Ipilimumab, which targets both PD-1 and CTLA-4 pathways, has demonstrated promising results in clinical trials. 3) Tisotumab vedotin, an antibody-drug conjugate targeting tissue factor, has shown efficacy in recurrent or metastatic cervical cancer and is being explored for ovarian cancer. 4) Adoptive T-cell therapies, such as CAR-T cells, are being investigated for their potential in targeting ovarian cancer cells.

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Chemotherapy

TransCon IL-2 β/γ + Pembrolizumab/Chemotherapy for Solid Tumor Cancers (IL Believe Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Ascendis Pharma Oncology Division A/S

Eligibility Criteria Checklist

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

Must have

Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts

Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Must not have

Significant cardiac disease

A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using Fridericia's QT correction formula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TransCon IL-2 β/γ for adults with advanced or spreading solid tumors. The drug aims to boost the immune system to better fight cancer by slowly releasing a molecule that helps immune cells attack cancer cells. TransCon IL-2 β/γ is a new long-acting drug currently being evaluated.

Who is the study for?

Adults with advanced solid tumors who are at least 18, have good organ function and a life expectancy over 12 weeks. They must not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and have no severe allergies to study drugs or significant health issues like uncontrolled infections or heart disease.

What is being tested?

The trial is testing TransCon IL-2 β/γ alone or combined with Pembrolizumab and/or chemotherapy in adults with advanced solid tumors. It's an early-phase study assessing different doses to find the safest and most effective levels for treatment.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to TransCon IL-2 β/γ or Pembrolizumab, such as inflammation in various organs, infusion-related reactions, fatigue, digestive problems, skin changes, 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 cancer is advanced and cannot be cured with surgery or radiation, except as part of initial treatment.

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I can care for myself and am up and about more than 50% of my waking hours.

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My cancer can be entirely removed with surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Exclusion Criteria

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

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I have a serious heart condition.

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My heart's electrical cycle is longer than usual.

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I have had treatments with IL-2 or TLR agonists for my cancer.

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I am currently breastfeeding or have tested positive for pregnancy.

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I am HIV positive or have an active hepatitis B or C infection.

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I do not have any untreated infections.

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I have symptoms from cancer spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Safety and Tolerability

Secondary study objectives

Duration of Response

Event free survival (EFS) by RECIST 1.1

Major Pathologic Response

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

13Treatment groups

Experimental Treatment

Group I: Part 4 Combination Dose OptimizationExperimental Treatment2 Interventions

TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab

Group II: Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgeryExperimental Treatment2 Interventions

(Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group III: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgeryExperimental Treatment3 Interventions

TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group IV: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgeryExperimental Treatment4 Interventions

TransCon IL-2 β/γ using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group V: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 AgonistExperimental Treatment2 Interventions

TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination

Group VI: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC ChemoExperimental Treatment2 Interventions

TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination

Group VII: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgeryExperimental Treatment3 Interventions

TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group VIII: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapyExperimental Treatment1 Intervention

TransCon IL-2 β/γ monotherapy

Group IX: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)Experimental Treatment2 Interventions

TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)

Group X: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumabExperimental Treatment2 Interventions

TransCon IL-2 β/γ + trastuzumab

Group XI: Part 3 Combination Dose ExpansionExperimental Treatment2 Interventions

TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab

Group XII: Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with PembrolizumabExperimental Treatment2 Interventions

TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D

Group XIII: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γExperimental Treatment1 Intervention

TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Pembrolizumab

2017

Completed Phase 3

~3150

Surgery

2000

Completed Phase 3

~2490

Chemotherapy drug

2020

N/A

~70

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include chemotherapy, targeted therapy, and immune modulation. Chemotherapy, such as paclitaxel and carboplatin, works by damaging the DNA of cancer cells, leading to cell death. Targeted therapies, like PARP inhibitors and angiogenesis inhibitors (e.g., bevacizumab), specifically target cancer cell pathways to inhibit tumor growth and spread. Immune modulation, including investigational drugs like TransCon IL-2 β/γ, aims to enhance the body's immune response against cancer cells by modulating the IL-2 pathways, which can increase the activity of immune cells such as T-cells and natural killer cells. This is particularly important for ovarian cancer patients as it offers a potential for more precise and effective treatment options with potentially fewer side effects compared to traditional therapies.