Avelumab for Metastatic Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Endometrial CancerAvelumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing Avelumab as a possible treatment for endometrial cancer that has come back or spread. It will be tested alone and with Talazoparib or Axitinib.

Eligible Conditions
  • Metastatic Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 2 years

2 years
Activity Of Avelumab and Avelumab plus Talazoparib In Patients With Recurrent Or Persistent Endometrial Cancer
Clinical Activity of Avelumab plus Axitinib in Patients with MSS Recurrent or Persistent Endometrial Cancer
Clinical Activity of Combination Avelumab/Axitinib
Duration of Overall Survival
Duration of Progression Free Survival as Assessed by RECIST 1.1
Immune-Related Objective Response
Immune-Related Progression-Free Survival (irPFS)
Number of Participants Receiving Avelumab/Axitinib With Treatment-Related Adverse Events as Assessed by CTCAE v4.1
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Avelumab
20%Cough
20%Decreased appetite
19%Dyspnoea
18%Fatigue
14%Nausea
14%Infusion related reaction
14%Asthenia
13%Anaemia
13%Pyrexia
13%Weight decreased
12%Back pain
11%Diarrhoea
11%Constipation
10%Disease progression
10%Vomiting
8%Headache
8%Rash
7%Upper respiratory tract infection
7%Arthralgia
7%Pruritus
7%Chills
6%Musculoskeletal pain
6%Hypothyroidism
6%Haemoptysis
6%Productive cough
6%Pain in extremity
5%Insomnia
5%Oedema peripheral
4%Myalgia
3%Pleural effusion
2%Neuropathy peripheral
2%Pneumonia
2%Chronic obstructive pulmonary disease
2%Death
2%Malaise
2%Stomatitis
1%Neutropenia
1%Peripheral sensory neuropathy
1%Pain
1%Acute respiratory failure
1%Sepsis
1%Respiratory tract infection
1%Metastases to central nervous system
1%Pericardial effusion
1%Hyperglycaemia
1%White blood cell count decreased
1%Depressed level of consciousness
1%Acute kidney injury
1%Confusional state
1%Mucosal inflammation
1%Cardiac arrest
1%Cardiac tamponade
1%Colitis
1%Pulmonary embolism
1%Hypercalcaemia
1%Respiratory failure
1%Interstitial lung disease
1%Hypoxia
1%Femoral neck fracture
1%Atrial fibrillation
1%Metastases to bone
1%Hypersensitivity
1%Alopecia
1%Pneumonitis
1%Lung infection
1%Malignant pleural effusion
1%Abdominal pain
1%Hyperkalaemia
1%Superior vena cava syndrome
1%Neutrophil count decreased
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02395172) in the Avelumab ARM group. Side effects include: Cough with 20%, Decreased appetite with 20%, Dyspnoea with 19%, Fatigue with 18%, Nausea with 14%.

Trial Design

4 Treatment Groups

MSS Endometrial Cancer
1 of 4
Pole Mutated Endometrial Cancer
1 of 4
MSS Avelumab/Talazoparib Combination Arm
1 of 4
MSS Avelumab/Axitinib Combination Arm
1 of 4

Experimental Treatment

105 Total Participants · 4 Treatment Groups

Primary Treatment: Avelumab · No Placebo Group · Phase 2

MSS Endometrial Cancer
Drug
Experimental Group · 1 Intervention: Avelumab · Intervention Types: Drug
Pole Mutated Endometrial Cancer
Drug
Experimental Group · 1 Intervention: Avelumab · Intervention Types: Drug
MSS Avelumab/Talazoparib Combination ArmExperimental Group · 2 Interventions: Avelumab, Talazoparib · Intervention Types: Drug, Drug
MSS Avelumab/Axitinib Combination ArmExperimental Group · 2 Interventions: Avelumab, Axitinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Talazoparib
FDA approved
Axitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

PfizerIndustry Sponsor
4,307 Previous Clinical Trials
7,109,859 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,711 Total Patients Enrolled
1 Trials studying Metastatic Endometrial Cancer
16 Patients Enrolled for Metastatic Endometrial Cancer
Panagiotis Konstantinopoulos, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
1 Previous Clinical Trials
5 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The MSI-H status of a patient with endometrial cancer is determined by their lack of expression of the mismatch repair genes MSH2, MSH6, MLH1 and PMS2
Patients with endometrial carcinoma must have had one prior chemotherapeutic regimen, but there is no upper limit of prior therapies
Cancers that are MSS as determined by normal immunohistochemical nuclear expression of all the mismatch repair genes MSH2, MSH6, MLH1 and PMS2, and have not been sequenced for POLE mutations (i.e
You are allowed to take hormonal therapy before the surgery.
Patients are not allowed to take any drugs that target the PD-1/PD-L1 pathway.
Cancers that have a mutation in the exonuclease domain (amino acids 268-471) of the polymerase e gene (POLE) will be classified as part of this patient cohort
In order to be a patient eligible for receive treatment with PARP inhibitors, the individual must have measurable disease as defined by RECIST 1.1
Patients in the avelumab/axitinib cohort may not have received prior axitinib.
The study does not include children because insufficient dosing or adverse event data are currently available on the use of Avelumab, talazoparib, and/or axitinib in participants < 18 years of age
People in the avelumab/talazoparib group should not have received any previous PARP inhibitor treatment.