What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and radiation therapy, can have a range of side effects. Chemotherapy often causes hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic effects such as nausea, vomiting, fatigue, and alopecia. Targeted therapies, including antiangiogenic agents, can lead to hypertension, hypothyroidism, diarrhea, and cardiovascular effects. Radiation therapy may cause localized side effects like skin irritation, fatigue, and pneumonitis. Intratumoral administration via devices like CIVO aims to minimize systemic side effects by delivering microdose quantities directly into the tumor, potentially reducing the overall toxicity profile.

What prior FDA approvals exist?

The FDA has approved several therapies for the treatment of solid tumors that involve localized administration within the tumor microenvironment. Notable examples include talimogene laherparepvec (T-VEC), an oncolytic viral therapy for melanoma, and pembrolizumab, an immune checkpoint inhibitor used in various cancers. These treatments aim to enhance the immune response directly within the tumor site. Additionally, the use of intratumoral injections of agents like nivolumab and ipilimumab has shown promise in clinical trials, reflecting a growing interest in localized pharmacodynamics to improve therapeutic outcomes in solid tumors.

What other types of research exist?

Promising novel alternatives to the CIVO device for intratumoral administration of anti-cancer therapies in solid tumor patients include: 1) Intralesional talimogene laherparepvec (T-VEC), which has shown success in treating advanced-stage melanoma, particularly in patients refractory to immune checkpoint inhibitors. 2) Solubilized vemurafenib administered via nasogastric tube, providing an alternative for patients unable to take oral medications. 3) Combination treatments involving bevacizumab, pegylated liposomal doxorubicin, and regional abdominal hyperthermia, which have demonstrated excellent response and low toxicity in heavily pretreated ovarian cancer patients. These alternatives offer different administration routes and target various solid tumor types, providing flexibility and potential efficacy for diverse patient needs.

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Other

Intratumoral Microdosing for Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for solid tumors include immune checkpoint inhibitors, targeted therapies, and chemotherapy. Immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 antibodies, work by enhancing the body's immune response against cancer cells. Targeted therapies, like HER2 inhibitors and VEGF inhibitors, block specific molecules involved in tumor growth and angiogenesis. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are crucial for solid tumor patients as they can directly affect the tumor microenvironment, potentially improving treatment efficacy and reducing systemic side effects. Intratumoral administration, as studied with the CIVO device, allows for localized delivery of these therapies, providing insights into their pharmacodynamics and optimizing personalized treatment strategies.

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)

Must not have

Female patients who are: Both lactating and breastfeeding, OR Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours-7 days after microdose injection

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device to inject small amounts of cancer drugs directly into tumors of patients undergoing surgery. The device marks where each drug is injected, allowing researchers to see how different parts of the tumor respond. This helps test cancer drugs early without causing widespread side effects. The device has been shown to induce strong, easily tracked, drug-specific responses in tumors while avoiding toxicity, setting the stage for its application in clinical trials.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently breastfeeding or have tested positive for pregnancy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Number of Patients with Adverse Events

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3130

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include immune checkpoint inhibitors, targeted therapies, and chemotherapy. Immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 antibodies, work by enhancing the body's immune response against cancer cells. Targeted therapies, like HER2 inhibitors and VEGF inhibitors, block specific molecules involved in tumor growth and angiogenesis. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are crucial for solid tumor patients as they can directly affect the tumor microenvironment, potentially improving treatment efficacy and reducing systemic side effects. Intratumoral administration, as studied with the CIVO device, allows for localized delivery of these therapies, providing insights into their pharmacodynamics and optimizing personalized treatment strategies.