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Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC

ConditionPancreatic Cancer Metastatic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must have histologically proven metastatic pancreatic cancer. Histologies including acinar cell carcinoma, carcinoma, ductal carcinoma, ductal adenocarcinoma, poorly differentiated or adenosquamous carcinoma are allowed.

Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certified assay. Somatic pathogenic alterations detected on circulating tumor DNA need confirmation on tumor tissue NGS. Germline pathogenic alterations in BRCA1, BRCA2 or PALB2 do not require further confirmation on tumor NGS. All genomic reports be verified in writing (via email) by site and/or overall PI.

Participants must have measurable disease per RECIST version 1.1.

Participant must have at least one disease site which is amenable to safe biopsy and must agree to pre- and on-treatment biopsies (core, incisional, or excisional biopsy) of tumor site. In select cases biopsies can be waived after discussion with the Sponsor Investigator.

Disqualifiers

Participants with neuroendocrine tumors of the pancreas are excluded.

Received prior treatment with anti-CTLA-4 therapy

Received prior immune-checkpoint anti-PD-1/PD-L1 therapy

Received prior approved systemic anticancer therapy within 2 weeks or within its 5 half-lives prior to study treatment, whichever is shorter. Note: Long-standing hormonal therapy for prostate, breast, uterine, and adrenal cancer may be permitted to continue if it is deemed to be in the best interest of the patient, after discussion with the Sponsor Investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • vilastobart (XTX101)

    Drug

    100mg administered once every 6 weeks (Day 1 of every 6-week cycle) by intravenous infusion (IV) over about 90-140 minutes. This will continue for up to 4 6-week cycles (4 doses).

  • Retifanlimab

    Drug

    375 mg administered once every 3 weeks (Days 2 and 23 of every 6-week cycle) by intravenous infusion over about 30 minutes. This will continue for up to 12 months.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Vilastobart + RetifanlimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The primary endpoint is objective response rate for combination of vilastobart with retifanlimab. Response is measured using RECISTv1.1 and evaluated independently. Evaluation of the primary endpoint will follow a Simon's two-stage design. The objective response rate will be reported with an exact binomial 95% confidence interval.

Time frame
Up to 1 year from baseline.

Secondary outcomes

1

Progression free survival (PFS)

Progression is measured using RECIST v1.1 defined as measured from the start of the treatment with vilastobart to the date of either documentation of disease progression or death. The Kaplan-Meier method will be used to estimate PFS.

Time frame
From Day 1 through end of follow up (up to 3 years from registration)
2

Overall survival (OS)

Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. The Kaplan-Meier method will be used to estimate OS.

Time frame
Up to 3 years from registration
3

Duration of response (DoR)

To measure the durability of response of the combination regimen as measured by duration of response (DoR), the duration of overall response is measured from the time RECIST v1.1 measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).

Time frame
From Day 1 through end of follow up (up to 3 years from registration)
4

Overall clinical benefit

Overall clinical benefit is defined as complete response (CR), or partial response (PR) or stable disease (SD) for at least 16 weeks as assessed by RECISTv1.1. They will be summarized using binomial proportions along with exact 95% CI.

Time frame
From baseline through up to 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Xilio Development, Inc.

Collaborator

Incyte Corporation

Collaborator

Lustgarten Foundation

Collaborator

Source ClinicalTrials.gov

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