All > Mci > Soft Tissue Sarcoma

Retifanlimab for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarcoma+2 MoreRetifanlimab - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug, Retifanlimab, to see if it is safe and effective when combined with two existing chemotherapy drugs, gemcitabine and docetaxel, to treat patients with soft tissue sarcoma.

Eligible Conditions
  • Sarcoma
  • Soft Tissue Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Ascorbate
1
Metronomic dosing
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Gemcitabine

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
Phase II: proportion of patients that are progression-free at 24 weeks by RECIST v1.1

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Ascorbate
1
Metronomic dosing
1
Gemcitabine

Side Effects for

Retifanlimab 500 mg
23%Asthenia
21%Diarrhoea
18%Fatigue
16%Anaemia
16%Nausea
15%Vomiting
13%Decreased appetite
13%Constipation
12%Dyspnoea
12%Cough
12%Pruritus
11%Pyrexia
10%Rectal haemorrhage
10%Hypothyroidism
9%Headache
9%Weight decreased
9%Back pain
9%Arthralgia
7%Abdominal pain
7%Aspartate aminotransferase increased
7%Proctalgia
7%Urinary tract infection
6%Insomnia
5%Cystitis
5%Rash
5%Hypokalaemia
3%Pelvic pain
3%General physical health deterioration
2%Inadequate analgesia
2%Pneumonia
2%Pleural effusion
2%Haematuria
2%Sepsis
2%Hypercalcaemia
2%Intestinal obstruction
1%Pulmonary embolism
1%Cholecystitis
1%Pain
1%Respiratory failure
1%Pancreatic carcinoma
1%Body temperature increased
1%Urinary retention
1%Purpura
1%Skin infection
1%Tumour embolism
1%Thrombosis
1%Hepatitis
1%Ureteric compression
1%Tumour pain
1%Mental status changes
1%Acute respiratory failure
1%Adrenal insufficiency
1%Anal abscess
1%Dehydration
1%Acute kidney injury
1%Blood bilirubin increased
1%Cholecystitis acute
1%Coma hepatic
1%Gastric ulcer
1%Pseudomonas infection
1%Venous thrombosis limb
1%Lyme disease
1%Gastroenteritis
1%Bone pain
1%Diffuse large B-cell lymphoma
1%Pelvic infection
1%Interstitial lung disease
1%Catheter site pain
1%Herpes zoster
1%Cholangitis
1%Colonic fistula
1%Peritonitis
1%Cellulitis
1%Large intestinal obstruction
1%Hydronephrosis
1%Ileus
1%Superior mesenteric artery syndrome
1%Transitional cell carcinoma
1%Cognitive disorder
1%Immune-mediated enterocolitis
1%Device related infection
1%Lymphangiosis carcinomatosa
1%Proctitis haemorrhagic
1%Stoma site infection
1%Femur fracture
1%Pneumocystis jirovecii pneumonia
1%Fall
1%Flank pain
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03597295) in the Retifanlimab 500 mg ARM group. Side effects include: Asthenia with 23%, Diarrhoea with 21%, Fatigue with 18%, Anaemia with 16%, Nausea with 16%.

Trial Design

9 Treatment Groups

Phase I: Safety Run-In / Dose Level 0
1 of 9
Other Soft tissue sarcoma/STS
1 of 9
Liposarcoma/LPS
1 of 9
Leiomyosarcoma/LMS
1 of 9
Undifferentiated Pleomorphic Sarcoma/Myxofibrosarcoma
1 of 9
Vascular Sarcoma
1 of 9
Phase I: Dose De-escalation Level 1
1 of 9
Phase I: Dose De-escalation Level -1
1 of 9
Phase I: Dose De-escalation Level -2
1 of 9

Experimental Treatment

74 Total Participants · 9 Treatment Groups

Primary Treatment: Retifanlimab · No Placebo Group · Phase 1 & 2

Phase I: Safety Run-In / Dose Level 0Experimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Other Soft tissue sarcoma/STSExperimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Liposarcoma/LPSExperimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Leiomyosarcoma/LMSExperimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Undifferentiated Pleomorphic Sarcoma/MyxofibrosarcomaExperimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Vascular SarcomaExperimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase I: Dose De-escalation Level 1Experimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase I: Dose De-escalation Level -1Experimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase I: Dose De-escalation Level -2Experimental Group · 3 Interventions: Retifanlimab, Docetaxel, Gemcitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
Not yet FDA approved
Docetaxel
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,334 Total Patients Enrolled
63 Trials studying Sarcoma
13,787 Patients Enrolled for Sarcoma
Incyte CorporationIndustry Sponsor
315 Previous Clinical Trials
46,501 Total Patients Enrolled
3 Trials studying Sarcoma
83 Patients Enrolled for Sarcoma
Sandra P D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Primary tumor cannot be safely removed surgically, or primary tumor would benefit from systemic therapy prior to a surgical approach.
You must consent to mandatory tumor biopsy (if deemed safe and feasible) for research studies at screening, if archival tissue is not available, and at C1D15, C3D15.
References

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