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Intratumoral Microdosing for Cancer

Q: How many volunteers are being recruited for the research investigation?

Affirmative. According to clinicaltrials.gov, the initial posting for this experiment was on July 26th 2021 and has been revised most recently on September 29th 2022. The trial is currently seeking 24 individuals who can be found at 7 different medical centres across the country.

Q: In what quantity of healthcare facilities is this trial being conducted?

Currently, seven clinical sites are enrolling participants in this trial; these locations include Seattle, Shreveport, and Bronx, as well as four other urban centres. It is recommended that those interested sign up at the site closest to them in order to reduce travel needs.

Q: Could you elucidate the primary indications for Pembrolizumab?

Pembrolizumab is often employed to treat unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, as well as microsatellite instability high, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, and cases of high risk recurrence.

Q: Are there still opportunities to participate in this investigation?

As seen on the clinicaltrials.gov website, enrollment for this medical trial began in July 2021 and was last modified near the end of September 2022; it is currently open to participants.

Q: Have any additional experiments been conducted utilizing Pembrolizumab?

Pembrolizumab was initially investigated at the City of Hope Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in 1997. To date, there have been 2645 completed trials and 2852 that are actively recruiting participants; notably a large number of these are based in Seattle, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>.

Phase < 1

Recruiting

Research Sponsored by Presage Biosciences

Eligibility Criteria Checklist

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

Must have

Pathologic diagnosis of [solid tumors] indicated in the relevant substudy(ies)

Male or female ≥ 18 years of age at Visit 1 (Screening)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours-7 days after microdose injection

Awards & highlights

Study Summary

This trial is designed to study how anti-cancer drugs work in the body when given in small doses intratumorally. The trial will use the CIVO device and will include multiple investigational agents and combinations.

Who is the study for?

Adults with surface accessible solid tumors scheduled for surgery can join. They must be able to follow the study plan and agree to use effective contraception or abstain from sex. Excluded are those with tumors near critical structures, pregnant or breastfeeding women, and anyone with serious illnesses that could affect participation.Check my eligibility

What is being tested?

The trial tests how anti-cancer drugs like Pembrolizumab and its combinations work inside tumors when given in tiny amounts using a device called CIVO before surgical removal of the tumor. It aims to understand drug effects directly within the tumor environment.See study design

What are the potential side effects?

While specific side effects aren't listed due to microdosing, typical reactions may include immune-related issues, infusion reactions, fatigue, skin changes, flu-like symptoms, and potential impact on normal organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer type matches one of the study's specific cancer types.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours-7 days after microdose injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours-7 days after microdose injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours-7 days after microdose injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quantification of Selected Pharmacodynamic Biomarkers as Specified in Substudies by IHC, ISH, and/or Spatial Biology Platforms

Secondary outcome measures

Number of Patients with Adverse Events

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rilvegostomig, Volrustomig, Sabestomig, PembrolizumabExperimental Treatment4 Interventions

HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, and pembrolizumab alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaIndustry Sponsor

1,203 Previous Clinical Trials

4,178,010 Total Patients Enrolled

Presage BiosciencesLead Sponsor

8 Previous Clinical Trials

85 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,656 Total Patients Enrolled

Media Library

CIVO Intratumoral Microdosing (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04541108 — Phase < 1

Solid Tumors Research Study Groups: Rilvegostomig, Volrustomig, Sabestomig, Pembrolizumab

Solid Tumors Clinical Trial 2023: CIVO Intratumoral Microdosing Highlights & Side Effects. Trial Name: NCT04541108 — Phase < 1

CIVO Intratumoral Microdosing (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541108 — Phase < 1

Frequently Asked Questions

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

How many volunteers are being recruited for the research investigation?

"Affirmative. According to clinicaltrials.gov, the initial posting for this experiment was on July 26th 2021 and has been revised most recently on September 29th 2022. The trial is currently seeking 24 individuals who can be found at 7 different medical centres across the country."

Answered by AI

In what quantity of healthcare facilities is this trial being conducted?

"Currently, seven clinical sites are enrolling participants in this trial; these locations include Seattle, Shreveport, and Bronx, as well as four other urban centres. It is recommended that those interested sign up at the site closest to them in order to reduce travel needs."

Answered by AI

Could you elucidate the primary indications for Pembrolizumab?

"Pembrolizumab is often employed to treat unresectable melanoma, as well as microsatellite instability high, squamous cell carcinoma, and cases of high risk recurrence."

Answered by AI

Are there still opportunities to participate in this investigation?

"As seen on the clinicaltrials.gov website, enrollment for this medical trial began in July 2021 and was last modified near the end of September 2022; it is currently open to participants."

Answered by AI

Have any additional experiments been conducted utilizing Pembrolizumab?

"Pembrolizumab was initially investigated at the City of Hope Comprehensive Cancer Center in 1997. To date, there have been 2645 completed trials and 2852 that are actively recruiting participants; notably a large number of these are based in Seattle, Washington."

Answered by AI