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Colorectal CancerPhase 2NCT05900648

Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

A Phase 2 study testing Regorafenib and XmAb20717 in people with Colorectal Cancer and Colon Cancer, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving therapy with regorafenib and XmAb20717 (also known as vudalimab). ctDNA is genetic material from tumor cells that can be found and measured in the blood Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Colon Cancer, Rectum Cancer
What is being tested?
Regorafenib and XmAb20717
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
17 May 2023to 9 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of CRC
  • Post-R0 resection of stages II, III, or IV CRC and all planned adjuvant therapies have been completed
  • No evidence of radiographic disease within 28 days (before or after) of a positive ctDNA assay
  • Evident MRD as defined by positive ctDNA assay. Patients may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count: ≥1,000/mcL
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  • Platelets: ≥100,000/mcL
  • Total bilirubin ≤1.5 x the upper limit of normal (ULN). Total bilirubin (≤3 x ULN) is allowed if Gilbert's syndrome is documented.
  • AST(SGOT)/ALT(SGPT): ≤3 × institutional ULN (≤5 x ULN for patients with liver involvement of their cancer).
  • Creatinine clearance ≥40 mL/min. Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = [(140 - age) x (weight in kg) ÷ [72 x (serum creatinine in mg/dL)] [0.85 if female]
  • ECOG performance status (PS) of 0 or 1 (Appendix A)
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of regorafenib in these patients, children <18 years of age are excluded from this study.
  • Able to understand and is willing to sign a written informed consent document.
  • The effects of Regorafenib and XmAb20717 on the developing human fetus are unknown. For this reason and because regorafenib appears to be teratogenic in animal models, women of child-bearing potential (refer to MDA Policy CLN 1114) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for at least 4 months after the last dose. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.) Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of administration.

Who cannot join

  • Concurrent treatment with drug with which the interactions are considered clinically significant by investigator (as outlined in section 5.2). Major surgical procedure or significant traumatic injury within 21 days before start of study medication. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment.
  • Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC.
  • Previous malignant disease (other than the target malignancy to be investigated in this trial) within 3 years prior to study treatment initiation.
  • Receipt of any organ transplantation, including allogeneic stem cell transplantation (exception: transplants that do not require immunosuppression, such as hair transplant).
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
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  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v4.03), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
  • Clinically significant cardiovascular/ cerebrovascular disease as follows: cerebral vascular accident / stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II), or serious cardiac arrhythmia.
  • Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
  • Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted).
  • Evidence of any serious bacterial viral (active HIV, HCV or HBV), parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug.
  • Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final EOT visit.
  • History of (non-infectious) pneumonitis that required steroids, ongoing pneumonitis, or history of interstitial lung disease.
  • Grade > 3 proteinuria ( > 3.5 g/24 hours)
  • Grade > 3 hypertension (systolic blood pressure > 160 or diastolic blood pressure > 100).

About this study

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving therapy with regorafenib and XmAb20717 (also known as vudalimab). ctDNA is genetic material from tumor cells that can be found and measured in the blood

Read the detailed description

Primary Objective:

  1. To determine the 6-month circulating tumor (ctDNA) clearance rate following 6 months of therapy with regorafenib and XmAb20717 (RX regimen) in patients with colorectal cancer (CRC) who present with radiographic occult molecular residual disease (MRD) after completing definitive standard-of-care (SOC) therapy.

Secondary Objectives:

  1. To determine the 3-month ctDNA clearance rate following RX treatment.
  2. To determine disease-free survival (DFS) following 6 months of RX treatment.
  3. To determine overall survival (OS) following 6 months of RX treatment.
  4. To determine the safety and tolerability of RX.

Exploratory Objectives:

  1. To determine changes in profiles of circulating lymphocytes and ctDNA (including time to ctDNA negative status, duration of ctDNA negative status, overall ctDNA negative rate, lead time from ctDNA detection to radiographic detection) during and following treatment with RX.
  2. To determine baseline characteristics in archival tumor and/or plasma that may predict clinical benefit or lack thereof (including but not limited to immune profiles of tumor-infiltrating lymphocytes, expression of immune markers in tumor cells and microenvironment, and tumor molecular profile).
Being tested
Regorafenib, XmAb20717
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Also called BAY 73-4506

    Given by PO

  • XmAb20717Drug

    Given by (IV) vein

Study groups in NCT05900648
Study groupRoleWhat they receive
Regorafenib and XmAb20717ExperimentalParticipants will receive regorafenib and XmAb20717 for up to 6 cycles (6 months). Participants will take regorafenib by mouth on Days 1-21 of each cycle. Participants will rest (not take regorafenib) on Days 21-28 of each cycle. Participants will also receive XmAb20717 by vein on Days 1 and 15 of each cycle. Each infusion should take about 60 minutes.
Receives: Drug: Regorafenib; Drug: XmAb20717

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start17 May 2023
  3. Primary completion9 Feb 2024
  4. Study completion9 Feb 2024

Why it stopped: 0 participant accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900648
Sponsor's protocol ID
2022-0726
Other IDs
NCI-2023-04464
Status last verified
Apr 2024
First submitted
31 May 2023
Last updated
29 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib and XmAb20717 in people with Colorectal Cancer and Colon Cancer, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.

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