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Immunomodulator

IO102-IO103 + Pembrolizumab for Cancer

Phase 2

Waitlist Available

Led By Jonathan W Riess, MD, MSc

Research Sponsored by IO Biotech

Eligibility Criteria Checklist

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

Must have

Patients with metastatic UBC (Arm C) not eligible for any cisplatin therapy, with advanced/unresectable or metastatic urothelial cancer and all solitary metastases biopsied to confirm diagnosis

Patients with histologically or cytologically confirmed metastatic NSCLC (Arm A) with no known sensitizing EGFR or ALK mutations and who have not received prior systemic treatment for their metastatic disease

Must not have

History of pneumonitis requiring steroids, active infection requiring systemic therapy, known HIV infection, or known history of Hepatitis B or active Hepatitis C virus infection

Diagnosis of immunodeficiency, active CNS metastases, or severe hypersensitivity to specified agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of a cancer vaccine and a medicine in patients with advanced lung, head and neck, or bladder cancers. The vaccine helps the immune system recognize and attack cancer cells, while the medicine boosts this immune response. The goal is to see if this combination is effective as an initial treatment. Combination therapies involving cancer vaccines and medicines that help the immune system have shown promise in inducing durable anti-tumor immune responses across various cancer types.

Who is the study for?

This trial is for adults with certain types of advanced cancers: metastatic NSCLC without specific mutations, recurrent or metastatic SCCHN, or mUBC ineligible for cisplatin therapy. Participants must not be pregnant or breastfeeding and agree to use contraception. Exclusions include immunodeficiency, active CNS metastases, severe allergies to trial drugs, recent live vaccines, autoimmune disease treatments within 2 years, prior cancer treatment in the last 6 months for metastatic disease.

What is being tested?

The study tests IO102-IO103 combined with pembrolizumab as a first-line treatment against three types of advanced cancers (NSCLC, SCCHN & mUBC). It's a Phase II trial aiming to assess safety and effectiveness. Patients are grouped based on their cancer type and receive the combination therapy.

What are the potential side effects?

Potential side effects may include immune-related reactions such as inflammation in various organs; infusion-related symptoms; fatigue; skin issues; hormonal gland problems like thyroid dysfunction; possible liver toxicity; 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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I have advanced bladder cancer and cannot receive cisplatin therapy.

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My advanced lung cancer has no EGFR or ALK mutations and I haven't had systemic treatment for it.

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My throat cancer has returned or spread, is incurable with surgery or radiation, and I haven't had any prior therapy.

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I am using contraception or not pregnant/breastfeeding if female.

Exclusion Criteria

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

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I have not had severe lung inflammation, active infections needing strong medication, or known HIV/Hepatitis B/C.

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I do not have an immune system disorder, brain metastases, or severe allergies to certain drugs.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have not received a live vaccine in the last 30 days.

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My doctor expects I have less than 3 months to live due to my rapidly worsening condition.

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I had a severe reaction to previous immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment for reporting.