ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study | NCT06095674

Studies
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

NCT06095674

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Unknown status

Last Update Posted

Oct 23, 2023Actual

Enrollment

30Estimated

Phase

Phase 1

Conditions

Cervical Cancer

Interventions

Anti-PD-1 antibody balstilimab

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2024Estimated

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Sep 4, 2023

First Submission Date that Met QC Criteria

Oct 17, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2023

Last Update Posted Date

Oct 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

C.H. (Stijn) Mom, Principle investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Name	Class
Dutch Cancer Society	OTHER
Agenus Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The ITHACA study is a phase I study evaluating the safety and toxicity of a peritumorally injected PD-1 checkpoint inhibitor, in combination with a multifunctional CTLA-4 inhibitor, in early-stage cervical cancer.

Detailed Description

In this single arm, open label phase I study, the investigators will study the safety and toxicity of the combination of a PD-1 checkpoint inhibitor and a multifunctional CTLA-4 inhibitor when injected peritumorally prior to surgery in early-stage cervical cancer. Additional objectives are to describe dose limiting toxicities, to determine the maximum tolerated doses and to study the effects on the tumor and lymph node microenvironment, and on immune subsets in peripheral blood.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD-1 checkpoint inhibitor and CTLA-4 inhibitor	Experimental	Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.	Drug: Anti-PD-1 antibody balstilimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-PD-1 antibody balstilimab	Drug	Both antibodies will be neoadjuvantly administered around the cervical tumor.	PD-1 checkpoint inhibitor and CTLA-4 inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose limiting toxicity	Type and severity of side effects according to CTCAE v 5.0.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Maximum tolerated dose	The highest dose administered without unacceptable toxicity	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

early-stage cervical cancer
scheduled for (radical) hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

previous treatment with checkpoint inhibitors
use of immunosuppressive medication within 28 days of the injection of the study medication
history of other malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Constantijne H Mom, MD, PhD	Contact	+31205669111		c.mom@amsterdamumc.nl

Overall Officials

Name	Affiliation	Role
Constantijne H Mom, MD, PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC		Amsterdam			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided