IMSA101 + ICI for Advanced Cancer

Recruiting at 1 trial location

Overseen By Teresa Mooneyham

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ImmuneSensor Therapeutics Inc.

Must be taking: IMSA101

Disqualifiers: Discontinued IMSA101, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing treatment with IMSA101 and an immune checkpoint inhibitor.

What data supports the effectiveness of the drug IMSA101 + ICI for Advanced Cancer?

Research shows that immune checkpoint inhibitors (ICIs) are effective in improving survival and response rates in various cancers when combined with standard treatments. This suggests that combining ICIs with other therapies, like IMSA101, could potentially enhance treatment outcomes for advanced cancer patients. ^{1 2 3 4 5}

What safety data exists for IMSA101 + ICI treatment in humans?

Immune checkpoint inhibitors (ICIs) are generally better tolerated than traditional chemotherapy, but they can cause immune-mediated adverse events (imAEs) affecting the skin and gastrointestinal system, which are usually mild and manageable. However, there is an increased risk of severe side effects, including cardiovascular issues, when ICIs are combined with other treatments, so careful monitoring is essential. ^{6 7 8 9 10}

What makes the drug IMSA101 + ICI unique for treating advanced cancer?

IMSA101 combined with immune checkpoint inhibitors (ICIs) is unique because it potentially enhances the immune system's ability to fight cancer by targeting specific pathways, which may offer benefits over traditional treatments that do not involve the immune system. This combination could be particularly beneficial for patients who might not respond well to standard therapies. ^{1 3 11 12 13}

What is the purpose of this trial?

This is a rollover study from parent protocol IMSA101-101 for adult patients with advanced malignancies that were previously receiving IMSA101 and who would continue to receive benefit with study treatment of IMSA101 in combination with an immune checkpoint inhibitor (ICI).

Research Team

Teresa Mooneyham

Principal Investigator

ImmuneSensor Therapeutics

Eligibility Criteria

This trial is for adults with advanced solid tumors who were part of the IMSA101-101 study, are currently receiving IMSA101, and still seeing benefits. They must understand the consent form, have completed all assessments in the previous study, and agree to use two effective birth control methods if they can have children.

Inclusion Criteria

I am currently participating in the IMSA101-101 study and receiving IMSA101 treatment.

I agree to use two effective birth control methods during the study.

Deriving clinical benefit from study treatment, as determined by the investigator

Exclusion Criteria

Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment

Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMSA101 in combination with an immune checkpoint inhibitor (ICI) with treatment cycles of 28 days, and lesions injected every 2 weeks

12 months

Bi-weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Immune Checkpoint Inhibitor
• IMSA101

Trial Overview The trial continues treatment from a previous study by giving patients IMSA101 along with an immune checkpoint inhibitor (ICI). It's designed for those who've already shown positive responses to these treatments and aims to further assess their effectiveness.

Participant Groups

Group I: Combination Therapy Experimental Treatment 2 Interventions

IMSA101 + ICI

Who Is Running the Clinical Trial?

ImmuneSensor Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

60+

Findings from Research

In a study of 12,283 patients with advanced non-small cell lung cancer (NSCLC) and other cancers, only 7-8% received PD-1/PD-L1 immune checkpoint inhibitors, primarily as second-line treatments, highlighting their limited use before widespread adoption.

Overall survival (OS) was significantly better for patients starting treatment with surgery (up to 25.6 months for NSCLC) compared to those receiving radiation therapy (as low as 3.9 months for NSCLC), indicating that treatment type greatly influences patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and Survival in Advanced Non-Small Cell Lung Cancer, Urothelial, Ovarian, Gastric and Kidney Cancer: A Nationwide Comprehensive Evaluation. Sørup, S., Darvalics, B., Khalil, AA., et al.[2022]

In a study of 65 patients undergoing interventional oncology therapies combined with immune checkpoint inhibitors, only 10.8% experienced immune-related adverse events (irAEs), mostly mild and manageable, indicating a favorable safety profile for this combination treatment.

The study found no severe complications (grade 5) related to the procedures or irAEs within 90 days, suggesting that combining tumor-directed therapies with immune checkpoint inhibitors is safe and does not lead to unexpected toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. Leppelmann, KS., Mooradian, MJ., Ganguli, S., et al.[2021]

Immune checkpoint inhibitor (ICI) combination therapy significantly improves objective response rates (ORR), disease control rates (DCR), progression-free survival (PFS), and overall survival (OS) in patients with advanced malignancies, based on a meta-analysis of 10 studies involving 2410 patients.

While ICI combination therapy shows enhanced efficacy compared to monotherapy, it is associated with a higher incidence of severe adverse events, including fatigue, nausea, and elevated liver enzymes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor (ICI) combination therapy compared to monotherapy in advanced solid cancer: A systematic review. Ma, X., Zhang, Y., Wang, S., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Could immunoscore improve the prognostic and therapeutic management in patients with solid tumors? [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment and Survival in Advanced Non-Small Cell Lung Cancer, Urothelial, Ovarian, Gastric and Kidney Cancer: A Nationwide Comprehensive Evaluation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of anti-PD-1/PD-L1 combinations versus standard of care in cancer: a systematic review and meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of the revised International Prognostic Scoring System in treated patients with myelodysplastic syndromes. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of checkpoint inhibitors for cancer treatment: strategies for patient monitoring and management of immune-mediated adverse events. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Adverse effects of immuno-oncology drugs-Awareness, diagnosis, and management: A literature review of immune-mediated adverse events. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Cardiovascular toxicity of angiogenesis inhibitors and immune checkpoint inhibitors: synergistic anti-tumour effects at the cost of increased cardiovascular risk? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Advanced Practice Provider Perspective: Treating Patients With Immuno-Oncology Combination Therapy Across Tumor Types. [2020]

10. Australia pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor (ICI) combination therapy compared to monotherapy in advanced solid cancer: A systematic review. [2021]

11. Australia pubmed.ncbi.nlm.nih.gov

High levels of baseline serum IL-10 are associated with reduced clinical benefit from first-line immune checkpoint inhibitor therapy in advanced renal cell carcinoma. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Liver Metastases and Immune Checkpoint Inhibitor Efficacy in Patients With Refractory Metastatic Colorectal Cancer: A Secondary Analysis of a Randomized Clinical Trial. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer. [2022]