Neoplasms

All Conditions

Rare Diseases

Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury

MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

BN-Brachyury plus radiation

Gregory Cote, MD

The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.

BN Brachyury and Radiation in Chordoma

A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma

Includes Adverse Events that have injection site reactions indicated as the Adverse Event High Level Terms

Occurrence is defined as the number of participants who experienced an AE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per CTCAE v4.03 grade.

For hematology and chemistry laboratory parameters with CTCAE grading scales, toxicity grade shift is defined to evaluated categorical changes from baseline results to post-treatment results with respect to dichotomized CTCAE grading value (\<= Grade 2, \>= Grade 3). Grade 0=No adverse event or within normal limits; Grade 1=Mild adverse event; Grade 2=Moderate adverse event; Grade 3=Severe and undesirable adverse event; Grade 4=Life-threatening or disabling adverse event; Grade 5=Death related to adverse event. Higher scores mean worse outcome.

Rate of subjects achieving a best response of either Complete Response or Partial Response per modified RECIST v1.1. A modified RECIST v1.1 assessment is based on targeted radiated lesion(s). Progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation for this trial. Assessment for targeted radiated lesion(s): Complete Response (CR)=Disappearance of all target radiated lesions; Partial Response (PR)= \>=30% decrease in the sum of the longest diameter of target radiated lesions; Progressive Disease (PD) = \>=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%\<sum of the longest diameter of target radiated lesions\<20%.

Kaplan-Meier of the time interval from first treatment to objective tumor progression based on modified RECIST v1.1 or death. A modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) based on targeted radiated lesion(s) will be used. Progression will be defined as a 20% increase in the sum of the longest diameter of target radiated lesions in this trial, and a progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation used for this trial.

Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Best observed scores is the lowest score value observed.

Pain intensity and pain interference scores are summarized. Pain intensity scores includes pain items "Worst Pain in the Last Week", "Least Pain in the Last Week", and "Average Pain in the Last Week" and "Pain Right Now". Composite pain severity score (a mean severity score of the four pain items listed before). Composite pain interference score (a mean of the seven interference items). This will be calculated if at least four of the seven interference items have been completed on a given administration. Pain scores range from 0 to 10 with a score of 10 is the worst pain imaginable and a score of 0 is no pain. Worst observed scores is the highest score value observed.

Bavarian Nordic

All Adverse events collected during or following initiation of trial treatment or worsens in severity after the initiation of trial treatment. They are collected through the last scheduled visit (approximately 30 days after the last dose of trial product). Data were collected up to 29 months.

BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury

BN-Brachyury plus radiation: MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

BN-Brachyury Plus Radiation

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

HIV Antibody

Hepatitis B Surface

Hepatitis C Virus

Eastern Cooperative Oncology Group Performance Status. Grade 0 = Fully active, able to carry on all pre-disease performance without restriction. Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

ECOG Status

Historical Classification

Primary Tumor Site

Disease Status at Diagnosis

Current Disease Status

The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury

Bavarian Nordic Call Center

Evaluable Analysis Set conisits of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Objective Response Rate (ORR)

Evaluable Analysis Set consists of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Progression-free Survival (PFS)

Worst Pain in the Last Week - Baseline

Least Pain in the Last Week - Baseline

Average Pain in the Last Week - Baseline

Pain Right Now - Baseline

Composite Pain Severity Score - Baseline

Composite Pain Interference Score - Baseline

Worst Pain in the Last Week - Overall Treatment Period

Least Pain in the Last Week - Overall Treatment Period

Average Pain in the Last Week - Overall Treatment Period

Pain Right Now - Overall Treatment Period

Composite Pain Severity Score - Overall Treatment Period

Composite Pain Interference Score - Overall Treatment Period

Worst Pain in the Last Week - Change from Baseline in Overall Treatment Period

Least Pain in the Last Week - Change from Baseline in Overall Treatment Period

Average Pain in the Last Week - Change from Baseline in Overall Treatment Period

Pain Right Now - Change from Baseline in Overall Treatment Period

Composite Pain Severity Score - Change from Baseline in Overall Treatment Period

Composite Pain Interference Score - Change from Baseline in Overall Treatment Period

Evaluable Analysis Set consists of subjects who have completed two prime doses of MVA-BN-Brachyury and one booster dose of FPV-Brachyury prior to radiation, have completed radiation therapy, have at least 3 out of 4 booster doses of FPV-Brachyury in 14 weeks after radiation, have both baseline and at least one post-baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan for objective tumor evaluation.

Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores

Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores

Injection site pain

Injection site erythema

Injection site induration

Injection site swelling

Injection site rash

Injection site discomfort

Injection site irritation

Injection site oedema

Injection site pruritus

Number of Participants With Injection Site Reaction Adverse Events by Preferred Term

Treatment Emergent Adverse Events

Related Treatment Emergent Adverse Events

Severe Treatment Emergent Adverse Events

Severe Related Treatment Emergent Adverse Events

Serious Adverse Events

Related Serious Adverse Events

Adverse Events of Special Interest

Adverse Events Leading to Discontinuation

Adverse Events Leading to Death

Injection Site Reaction Adverse Events

The Full Analysis Set consists of all subjects who have enrolled and received any dose of MVA-BN Brachyury or FPV-Brachyury.

Frequencies of Participants With Occurrence, Severity and Seriousness of Adverse Events

Hemoglobin

Leukocytes

Lymphocytes

Neutrophils

Platelets

Alanine Aminotransferase

Albumin

Alkaline Phosphatase

Aspartate Aminotransferase

Bilirubin

Calcium

Creatinine

Glucose

Magnesium

Phosphate

Potassium

Sodium

Worst CTCAE Toxicity Grade Shift From Baseline in Laboratory Results (Hematology and Serum Chemistry)

Overall Study

Spots Global Cancer Trial Database for BN Brachyury and Radiation in Chordoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial