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Immunomodulator

IO102-IO103 + Pembrolizumab for Cancer

Phase 2
Recruiting
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
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

Study Summary

This trial is testing the safety and effectiveness of two drugs in combination as a first-line treatment for patients with three different types of cancer.

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.Check my eligibility
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.See study design
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.

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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR or PFS
Secondary outcome measures
Complete Response Rate (CRR)
Disease Control Rate (DCR)
Duration of Response (DoR)
+4 more
Other outcome measures
Exploratory Endpoint: Biomarkers
Exploratory Endpoint: Progression Free Survival according to iRECIST (iPFS)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (mUBC)Experimental Treatment1 Intervention
mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W
Group II: Arm B (SCCHN)Experimental Treatment1 Intervention
SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W
Group III: Arm A (NSCLC)Experimental Treatment1 Intervention
NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

Find a Location

Who is running the clinical trial?

AlmacIndustry Sponsor
3 Previous Clinical Trials
406 Total Patients Enrolled
IO BiotechLead Sponsor
8 Previous Clinical Trials
689 Total Patients Enrolled
TheradexIndustry Sponsor
33 Previous Clinical Trials
1,482 Total Patients Enrolled

Media Library

IO102-IO103 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05077709 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A (NSCLC), Arm B (SCCHN), Arm C (mUBC)
Non-Small Cell Lung Cancer Clinical Trial 2023: IO102-IO103 Highlights & Side Effects. Trial Name: NCT05077709 — Phase 2
IO102-IO103 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077709 — Phase 2

Frequently Asked Questions

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

Are there any opportunities for enrollment in this experiment currently?

"Affirmative. Details on clinicaltrials.gov reveal that this research is recruiting participants, with the original postdate being February 14th 2022 and last updated November 7th 2022. The trial requires 90 individuals from 6 different sites to participate in the study."

Answered by AI

How many participants are engaged in this experiment?

"The sponsor, IO Biotech, must acquire 90 qualifying participants to initiate the trial. Clinical sites located in Duarte (City of Hope) and Orange City (Mid Florida Hematology and Oncology Center) will be responsible for enrolling these individuals."

Answered by AI

What potential risks can be associated with IO102-IO103 and pembrolizumab when administered together?

"Our team at Power rated the safety of IO102-IO103 alongside pembrolizumab a 2 on a 3 point scale. This is due to its Phase 2 status, wherein there is evidence supporting safety but no data available that speaks to efficacy."

Answered by AI

What other experiments have been completed regarding the pairing of IO102-IO103 and pembrolizumab?

"The combined use of IO102-IO103 with pembrolizumab was initially tested in 2010 at City Of Hope. Since then, 249 trials have been completed and 961 are currently running around the world; many of these being located in Duarte, Florida."

Answered by AI

Are multiple facilities in the city administering this clinical experiment?

"6 clinical trial sites are currently offering participation in this medical research, including City of Hope (Duarte), Mid Florida Hematology and Oncology Center (Orange City), Oregon Health & Science University (Portland) plus 3 other locales."

Answered by AI

What maladies is IO102-IO103 in conjunction with pembrolizumab regularly employed to combat?

"IO102-IO103 in conjunction with pembrolizumab is often used to treat malignant neoplasms, especially those that are not amenable to resection. This combination can also help manage advanced melanoma, microsatellite instability high and diseases that have progressed after chemotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC
2022. "IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077709.
~0 spots leftby Apr 2024
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