trialsTrialActive

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

A phase 3 trial of Durvalumab, Tremelimumab, Cisplatin, Carboplatin and Gemcitabine in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer is a phase 3 interventional study registered as NCT02516241 by AstraZeneca, with 1126 participants enrolled, started 2015-11-02 and due to reach its primary completion in 2020-01-27. Interventions recorded: MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin and Gemcitabine. Results have been posted on the registry.

Setting

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

Phase

Phase 3

Sponsor

AstraZeneca

Registry

NCT02516241

Started

2015-11-02

Reported

2021

Enrolled

1,126 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

1,126 enrolled

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimarysurvival endpoint

Median 15.1 vs 12.1 months with Combination Therapy compared with Standard of Care; about 3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 15 percent lower chance of the event at any given time (hazard ratio 0.85).

The p-value (0.0751) means the difference could plausibly be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimarysurvival endpoint

Median 14.4 vs 12.1 months with Monotherapy compared with Standard of Care; about 2.3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 11 percent lower chance of the event at any given time (hazard ratio 0.89).

The p-value (0.3039) means the difference could plausibly be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoCsurrogate endpoint

Median 3.7 vs 2.3 months with Combination Therapy compared with Monotherapy; about 1.4 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Standard of Care 6.7 months.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoCresponse endpoint

36.3 vs 25.7 out of 100 had their tumour shrink with Combination Therapy compared with Monotherapy; 10.6 more per 100.
Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Standard of Care 49.1 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,126 enrolled.

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimary

HR 0.85 · p = 0.0751

Download

95% CI 13.1 to 18.0; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 10.9 to 14

Source

To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimary

HR 0.89 · p = 0.3039

Download

95% CI 10.4 to 17.3; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 10.4 to 15.0

Source

PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Download

95% CI 3.4 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 1.9 to 3.5 · 95% CI 5.7 to 7.3

Source

Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Combination Therapy36.3 of 100

n = 342

Monotherapy25.7 of 100

n = 346

Standard of Care49.1 of 100

n = 344

Download

Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimary	Combination Therapy	342	15.1 months	0.85	0.0751	link
	Standard of Care	344	12.1 months	0.85	0.0751	link
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimary	Monotherapy	209	14.4 months	0.89	0.3039	link
	Standard of Care	207	12.1 months	0.89	0.3039	link
PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC	Combination Therapy	342	3.7 months	-	-	link
	Monotherapy	346	2.3 months
	Standard of Care	344	6.7 months
Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC	Combination Therapy	342	36.3%	-	-	link
	Monotherapy	346	25.7%
	Standard of Care	344	49.1%

Connected

9top

Trial
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Shares Tremelimumab, Muscle-invasive and advanced bladder cancer, Durvalumab, Gemcitabine and the tag pipeline.
Trial
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Shares Tremelimumab, Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca and the tag pipeline.
Trial
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, AstraZeneca, Bladder & urothelial cancer and the tag pipeline.
Trial
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, Gemcitabine, AstraZeneca and the tag pipeline.
Trial
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Shares Tremelimumab, Durvalumab, Gemcitabine, AstraZeneca and the tag pipeline.

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedCytotoxic chemotherapy (platinum)

Carboplatin

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

ApprovedMonoclonal antibody (anti-PD-L1)

Durvalumab · Imfinzi

ApprovedNucleoside analogue (deoxycytidine)

Gemcitabine · Gemzar / Infugem

ApprovedMonoclonal antibody (anti-CTLA-4)

Tremelimumab · Imjudo

companies

AstraZeneca

Evidence strength58/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
1,126 enrolled+15
Primary endpoint: surrogate (response, pCR, detection)+8
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT02516241

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

A phase 3 trial of Durvalumab, Tremelimumab, Cisplatin, Carboplatin and Gemcitabine in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.

Setting

Phase

Phase 3

Sponsor

AstraZeneca

Registry

NCT02516241

Started

2015-11-02

Reported

2021

Enrolled

1,126 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

1,126 enrolled

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimarysurvival endpoint

Median 15.1 vs 12.1 months with Combination Therapy compared with Standard of Care; about 3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 15 percent lower chance of the event at any given time (hazard ratio 0.85).

The p-value (0.0751) means the difference could plausibly be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimarysurvival endpoint

Median 14.4 vs 12.1 months with Monotherapy compared with Standard of Care; about 2.3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 11 percent lower chance of the event at any given time (hazard ratio 0.89).

The p-value (0.3039) means the difference could plausibly be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoCsurrogate endpoint

Median 3.7 vs 2.3 months with Combination Therapy compared with Monotherapy; about 1.4 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Standard of Care 6.7 months.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoCresponse endpoint

36.3 vs 25.7 out of 100 had their tumour shrink with Combination Therapy compared with Monotherapy; 10.6 more per 100.
Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Standard of Care 49.1 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,126 enrolled.

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimary

HR 0.85 · p = 0.0751

Download

95% CI 13.1 to 18.0; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 10.9 to 14

Source

To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimary

HR 0.89 · p = 0.3039

Download

95% CI 10.4 to 17.3; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 10.4 to 15.0

Source

PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Download

95% CI 3.4 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication · 95% CI 1.9 to 3.5 · 95% CI 5.7 to 7.3

Source

Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Combination Therapy36.3 of 100

n = 342

Monotherapy25.7 of 100

n = 346

Standard of Care49.1 of 100

n = 344

Download

Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Setprimary	Combination Therapy	342	15.1 months	0.85	0.0751	link
	Standard of Care	344	12.1 months	0.85	0.0751	link
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Setprimary	Monotherapy	209	14.4 months	0.89	0.3039	link
	Standard of Care	207	12.1 months	0.89	0.3039	link
PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC	Combination Therapy	342	3.7 months	-	-	link
	Monotherapy	346	2.3 months
	Standard of Care	344	6.7 months
Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC	Combination Therapy	342	36.3%	-	-	link
	Monotherapy	346	25.7%
	Standard of Care	344	49.1%

Connected

9top

Trial
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Shares Tremelimumab, Muscle-invasive and advanced bladder cancer, Durvalumab, Gemcitabine and the tag pipeline.
Trial
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Shares Tremelimumab, Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca and the tag pipeline.
Trial
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, AstraZeneca, Bladder & urothelial cancer and the tag pipeline.
Trial
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, Gemcitabine, AstraZeneca and the tag pipeline.
Trial
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Shares Muscle-invasive and advanced bladder cancer, Gemcitabine, Bladder & urothelial cancer, Cisplatin and the tag pipeline.
Trial
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Shares Tremelimumab, Durvalumab, Gemcitabine, AstraZeneca and the tag pipeline.

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedCytotoxic chemotherapy (platinum)

Carboplatin

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

ApprovedMonoclonal antibody (anti-PD-L1)

Durvalumab · Imfinzi

ApprovedNucleoside analogue (deoxycytidine)

Gemcitabine · Gemzar / Infugem

ApprovedMonoclonal antibody (anti-CTLA-4)

Tremelimumab · Imjudo

companies

AstraZeneca

Evidence strength58/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
1,126 enrolled+15
Primary endpoint: surrogate (response, pCR, detection)+8
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT02516241

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Overview

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Overview

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies