IO102-IO103: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Storage conditions per clinical trial protocol. Peptide vaccines typically require refrigerated storage at 2-8 degrees C. Montanide ISA-51 adjuvant has separate storage requirements.
Protocol Quick-Reference
First-line advanced melanoma with pembrolizumab
Dosing
Amount
Per clinical trial protocol (proprietary dose)
Frequency
Induction then maintenance schedule
Duration
Until disease progression
Step-wise Titration
Administration
Route
SCSchedule
Per protocol (induction phase then maintenance)
Timing
Administered in combination with standard-dose checkpoint inhibitor therapy
โ Rotate injection sites
Cycle
Duration
Per clinical trial protocol
Repeatable
Yes
Preparation & Storage
Storage: Refrigerate at 2-8 degrees C per clinical trial protocol.
โ๏ธ Suggested Bloodwork (4 tests)
When:
Why:
When:
Why:
When:
Why:
When:
Why:
๐ก Key Considerations
- โInvestigational biologic - not approved by any regulatory authority
- โMust be combined with checkpoint inhibitor; not used as monotherapy
- โRequires Montanide ISA-51 adjuvant for immunogenicity
- โAdministration by trained clinical trial staff only
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Advanced Melanoma (First-Line, Combined with Anti-PD-1) | IO102 and IO103 peptides administered subcutaneously with Montanide ISA-51 adjuvant. Combined with standard-dose pembrolizumab (200 mg IV Q3W) or nivolumab. Specific peptide dose in milligrams is proprietary. | Subcutaneous injection per clinical trial schedule (induction then maintenance) | Treatment continues until disease progression or unacceptable toxicity | IO102-IO103 is administered as a combination with checkpoint inhibitors and is not used as monotherapy. The vaccine requires Montanide ISA-51 (incomplete Freund's adjuvant) as an immunological adjuvant to enhance the T cell response. Exact dosing is per clinical trial protocol. |
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๐Reconstitution Instructions
IO102-IO103 is an investigational product administered only within clinical trials. The peptides are formulated with Montanide ISA-51 adjuvant prior to subcutaneous injection. Preparation is performed by trained clinical trial staff according to the study protocol.
Recommended Injection Sites
- โSubcutaneous (clinical trial protocol-specified sites)
๐งStorage Requirements
Storage conditions per clinical trial protocol. Peptide vaccines typically require refrigerated storage at 2-8 degrees C. Montanide ISA-51 adjuvant has separate storage requirements.
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Investigational Status#
IO102-IO103 (Cylembio) is an investigational biologic that has not received regulatory approval. All dosing information is derived from clinical trial protocols. The FDA granted Breakthrough Therapy Designation in 2020 but subsequently recommended against filing a Biologics License Application based on the phase 3 dataset alone. Administration occurs only within clinical trials.
Clinical Trial Dosing Framework#
Combination with Checkpoint Inhibitors#
IO102-IO103 is exclusively used in combination with anti-PD-1 checkpoint inhibitors:
Phase 1/2 MM1636 (nivolumab combination):
- IO102 and IO103 peptides administered subcutaneously
- Montanide ISA-51 (incomplete Freund's adjuvant) used as immunological adjuvant
- Combined with nivolumab at standard dosing
- Induction phase followed by maintenance
Phase 3 IOB-013/KN-D18 (pembrolizumab combination):
- IO102-IO103 with Montanide ISA-51 adjuvant
- Combined with pembrolizumab 200 mg IV every 3 weeks
- Treatment until disease progression, unacceptable toxicity, or up to 35 cycles of pembrolizumab
Phase 2 Basket Trials (pembrolizumab combination):
- Same vaccine formulation and adjuvant
- Combined with pembrolizumab as first-line treatment
- Tested in NSCLC (PD-L1 TPS 50% or higher) and HNSCC (PD-L1 CPS 20 or higher)
Vaccine Administration Schedule#
Peptide vaccines typically follow an induction-maintenance schedule:
Induction Phase: More frequent vaccinations (e.g., weekly or biweekly) to prime and expand vaccine-specific T cells
Maintenance Phase: Less frequent vaccinations to maintain the immune response during ongoing checkpoint inhibitor therapy
The exact schedule and peptide doses are proprietary to IO Biotech and specified in each trial protocol.
Adjuvant: Montanide ISA-51#
Montanide ISA-51 is a water-in-oil emulsion adjuvant (incomplete Freund's adjuvant) that:
- Creates a depot at the injection site for sustained antigen release
- Enhances antigen-presenting cell uptake and processing
- Promotes robust and durable T cell responses
- Has an established safety record in cancer vaccine trials
The peptide-adjuvant emulsion must be prepared according to specific protocols to ensure proper formulation.
Administration Considerations#
Injection Requirements#
- Prepared and administered by trained clinical trial personnel
- Subcutaneous injection at protocol-specified sites
- Injection site rotation between administrations
- Monitor for injection site reactions (typically low-grade and transient)
Monitoring During Treatment#
Standard oncology monitoring applies, with additional considerations for checkpoint inhibitor combination:
| Test | Purpose | Frequency |
|---|---|---|
| Tumor imaging (CT/PET-CT) | RECIST response assessment | Per protocol (typically Q6-12 weeks) |
| CBC with differential | Hematologic monitoring | Per checkpoint inhibitor schedule |
| Comprehensive metabolic panel | Hepatic and renal function | Per checkpoint inhibitor schedule |
| Thyroid function | Immune-mediated thyroiditis | Per checkpoint inhibitor schedule |
| LDH | Melanoma prognostic marker | Baseline and periodic |
| Immune monitoring | Optional T cell and cytokine profiling | Per protocol |
Treatment Duration#
- IO102-IO103 vaccination continues per protocol schedule
- Checkpoint inhibitor continues per standard guidelines (typically up to 2 years for pembrolizumab, or until progression)
- Treatment is discontinued upon disease progression, unacceptable toxicity, or per investigator decision
Dosing Context#
IO102-IO103 represents a fundamentally different dosing paradigm from most peptides covered on this site. As a therapeutic cancer vaccine:
- It requires combination with a checkpoint inhibitor
- It requires an immunological adjuvant (Montanide ISA-51)
- Dosing aims to stimulate and maintain anti-tumor T cell responses, not achieve a specific pharmacokinetic target
- It is administered only in the oncology clinical trial setting
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.