A Phase II Multi-Arm (Basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination With Pembrolizumab, as First-Line Treatment for Patients With Metastatic NSCLC, SCCHN, or Metastatic mUBC

Plain English Summary

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC is a Phase 2 clinical trial sponsored by IO Biotech studying Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder. This trial tests a new combination therapy (IO102-IO103 and pembrolizumab) for advanced lung, head and neck, or bladder cancers. It is for patients with specific types of metastatic non-small cell lung cancer, squamous cell carcinoma of the head or neck, or urothelial bladder cancer who have not received prior treatment for their advanced disease. Participation involves receiving the study drugs and regular medical check-ups, including imaging and blood tests. Alternative treatments may include standard chemotherapy, immunotherapy, or targeted therapies, depending on the cancer type and patient's condition. The trial aims to enroll 63 participants.

Official Summary

A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with advanced (metastatic) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), or urothelial bladder cancer (UBC) can join. Patients must not have received prior treatment for their advanced cancer, with specific genetic mutations (EGFR/ALK) being excluded for lung cancer. Specific PD-L1 expression levels in the tumor are required for each cancer type. Participants must be at least 18 years old and have good organ function. This trial is studying Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how many patients respond to the treatment, meaning their tumors shrink or disappear, which indicates the therapy is working. The specific primary outcome measures are: ORR (From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new first-line treatments for advanced lung, head and neck, and bladder cancers, aiming to improve outcomes for patients who have limited options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder, where improved treatment options are needed.

Investor Insight

This trial explores a novel combination therapy in a significant market of advanced cancers, with potential to offer a new treatment option if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific cancer type and stage. Understand the potential side effects and how they will be managed during the trial. Be prepared for regular clinic visits for treatment administration and monitoring. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 63 participants

Interventions

• DRUG: IO102-IO103 in combination with pembrolizumab — The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides

Primary Outcomes

• ORR (From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years.)

Secondary Outcomes

• Progression Free Survival (PFS) (Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.)
• Duration of Response (DoR) (Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.)
• Complete Response Rate (CRR) (Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.)
• Disease Control Rate (DCR) (Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.)
• Overall Survival (OS) (From inform consent until death of any cause or withdrawal consent, whichever comes first, for up to 3 years.)

Full Eligibility Criteria

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed:

   Metastatic NSCLC (Arm A), who have not received prior systemic treatment for their metastatic disease and who have:

   • no known sensitizing EGFR or ALK mutations.

   or

   Metastatic SCCHN (Arm B) with no prior therapy and who have:

   • Histologically- or cytologically-confirmed recurrent or metastatic SCCHN considered incurable by local therapies. Tumors of nasopharyngeal origin (any histology) are excluded

   • Documented results of HPV status for oropharyngeal cancer.

   or

   Metastatic UBC (Arm C) with no prior therapy and not eligible for any cisplatin therapy:

   • Advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder or urethra (transitional cell and mixed transitional/non transitional cell histologies permitted but transitional cell histology must be the dominant histology)

   All solitary metastases must be biopsied to confirm diagnosis of metastases from primary indication
2. PD-L1 tumor expression or PD-L1 CPS (as confirmed prior to enrolment using the DAKO 22C3 assay, using local/central services):

   • Arm A (NSCLC): PD-L1 TPS ≥ 50%

   • Arm B (SCCHN): PD-L1 CPS ≥ 20; HPV +/-

   • Arm C (mUBC): PD-L1 CPS ≥ 10
3. A male participant able to father a child must agree to use contraception starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of treatment with IO102-IO103.
4. A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:

   • Not a woman of childbearing potential (WOCBP)

   • A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of chemotherapy.
5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial.
6. At least 18 years of age on day of signing informed consent
7. Have measurable disease per RECIST 1.1 as assessed by local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
8. Have provided a blood sample and archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides.
9. Have an ECOG performance status of 0 to 1.
10. If participant received major surgery, they must have recovered adequately from the adverse events and/or complications from the intervention prior to starting trial treatment.
11. Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of trial treatment.Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of trial treatment.

    Adequate organ function as defined by:
    * Haematology:

    Absolute neutrophil count ≥ 1500/µL or ≥ 1.5 x 109/L Platelets ≥ 100,000/µL or ≥ 100 x 109/L Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L • Renal: Creatinine ≤ 1.5 x ULN, or Measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min for patients with creatinine levels \> 1.5 x institutional ULN; GFR can also be used in place of creatinine or CrCl • Hepatic: Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels ≤3 x ULN AST and ALT ≤ 2.5 x ULN (≤ 5xULN for patients with liver metastases) Alkaline Phosphatase ≤ 2.5 x ULN

    • Endocrine: Thyroid stimulating hormone (TSH) within normal limits, or Total T3 is within normal limits, or Free T3 and free T4 are within the normal limits
    * Coagulation:

    International normalised ratio, PT or aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

    Exclusion Criteria:

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1. A WOCBP who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If at any time, a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137) other than for adjuvant or neoadjuvant treatment AND was discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE).
3. Has received prior systemic anti-cancer therapy in the first line setting for the participant's metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of metastatic diseas

Trial Locations

• City of Hope, Duarte, California, United States
• UC Davis Cancer Center, Sacramento, California, United States
• University of California San Diego, San Diego, California, United States
• Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
• Montefiore Medical Center, The Bronx, New York, United States
• University of Toledo Medical Center, Toledo, Ohio, United States
• Oregon Health & Science University, Portland, Oregon, United States
• University of Pennsylvania, Philadelphia, Pennsylvania, United States
• Virginia Cancer Specialists, Fairfax, Virginia, United States
• Hospital Universitario Virgen Macarena, Seville, Sevilla, Spain
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck
• Urothelial Carcinoma of the Bladder
• Metastatic Cancer
• Advanced Cancer
• Immunotherapy
• Cancer Treatment
• Oncology
• Tumor Microenvironment
• Immune Checkpoint Inhibitors

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