trialsTrialActive

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

A phase 2 trial of Avelumab and Sacituzumab govitecan in bladder & urothelial cancer, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) is a phase 2 interventional study registered as NCT05327530 by EMD Serono Research & Development Institute, Inc., with 256 participants enrolled, started 2022-08-17 and due to reach its primary completion in 2025-06-20. Interventions recorded: Avelumab, Sacituzumab Govitecan (SG), M6223, NKTR-255 and JB100. Results have been posted on the registry.

Setting

A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)

Phase

Phase 2

Sponsor

EMD Serono Research & Development Institute, Inc.

Registry

NCT05327530

Started

2022-08-17

Reported

2026

Enrolled

256 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

256 enrolled

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primarysurrogate endpoint

Median 11.2 vs 3.8 months with Avelumab + Sacituzumab Govitecan (SG) compared with Avelumab + JB100 (NCT02603432); about 7.4 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.
Put another way, the treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.36 to 0.81).

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.

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primarysurrogate endpoint

Median 5.4 vs 4.5 months with Avelumab + M6223 compared with Avelumab + JB100 (NCT02603432); about 0.9 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 5 percent lower chance of the event at any given time (hazard ratio 0.95, likely range 0.64 to 1.39).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
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.

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primarysurrogate endpoint

Median 5.6 vs 4.5 months with Avelumab + NKTR-255 compared with Avelumab + JB100 (NCT02603432); about 1.1 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 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.55 to 1.21).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
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.

Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])survival endpoint

Median 22.1 months with Avelumab + JB100 (NCT02603432).
Avelumab + Sacituzumab Govitecan (SG): NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication.
A median is a midpoint: half the people did better than this and half did worse.
Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.41 to 1.17).

The likely range for the hazard ratio crosses 1, so the difference could 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.

Caveats

These results apply to the people the trial enrolled: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley). 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.

256 enrolled.

HR 0.54 (0.36 to 0.81)

Download

95% CI 7.62 to 17.64; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.32 to 5.65

Source

HR 0.95 (0.64 to 1.39)

Download

95% CI 3.78 to 7.43; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.45 to 7.20

Source

HR 0.81 (0.55 to 1.21)

Download

95% CI 3.75 to 12.91; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.48 to 7.20

Source

Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])

HR 0.69 (0.41 to 1.17)

Download

NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 16.92 to 28.78

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + Sacituzumab Govitecan (SG)	74	11.17 months	0.54 (0.36 to 0.81)	-	link
	Avelumab + JB100 (NCT02603432)	74	3.75 months	0.54 (0.36 to 0.81)	-	link
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + M6223	72	5.42 months	0.95 (0.64 to 1.39)	-	link
	Avelumab + JB100 (NCT02603432)	74	4.5 months	0.95 (0.64 to 1.39)	-	link
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + NKTR-255	73	5.59 months	0.81 (0.55 to 1.21)	-	link
	Avelumab + JB100 (NCT02603432)	74	4.5 months	0.81 (0.55 to 1.21)	-	link
Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])	Avelumab + Sacituzumab Govitecan (SG)	24	NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication	0.69 (0.41 to 1.17)	-	link
	Avelumab + JB100 (NCT02603432)	40	22.05 months	0.69 (0.41 to 1.17)	-	link

Connected

6top

Trial
Avelumab Program Rollover Study
Shares Avelumab, Merck KGaA (EMD Serono), Immune checkpoint inhibitors and the tag pipeline.
Trial
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Shares Avelumab, Muscle-invasive and advanced bladder cancer, Sacituzumab govitecan, Bladder & urothelial cancer and the tag pipeline.
Trial
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedMonoclonal antibody (anti-PD-L1)

Avelumab · Bavencio

ApprovedADC

Sacituzumab govitecan · Trodelvy

companies

Merck KGaA (EMD Serono)

Evidence strength46/100 · Emerging

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

Phase 2+15
256 enrolled+12
Primary endpoint: time to progression or recurrence+14
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 NCT05327530

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

A phase 2 trial of Avelumab and Sacituzumab govitecan in bladder & urothelial cancer, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.

Setting

Phase

Phase 2

Sponsor

EMD Serono Research & Development Institute, Inc.

Registry

NCT05327530

Started

2022-08-17

Reported

2026

Enrolled

256 enrolled

Outcomes

4top

In plain words

What these results mean for people, not percentages

256 enrolled

Median 11.2 vs 3.8 months with Avelumab + Sacituzumab Govitecan (SG) compared with Avelumab + JB100 (NCT02603432); about 7.4 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.
Put another way, the treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.36 to 0.81).

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.

Median 5.4 vs 4.5 months with Avelumab + M6223 compared with Avelumab + JB100 (NCT02603432); about 0.9 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 5 percent lower chance of the event at any given time (hazard ratio 0.95, likely range 0.64 to 1.39).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
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.

Median 5.6 vs 4.5 months with Avelumab + NKTR-255 compared with Avelumab + JB100 (NCT02603432); about 1.1 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 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.55 to 1.21).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
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.

Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])survival endpoint

Median 22.1 months with Avelumab + JB100 (NCT02603432).
Avelumab + Sacituzumab Govitecan (SG): NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication.
A median is a midpoint: half the people did better than this and half did worse.
Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.41 to 1.17).

The likely range for the hazard ratio crosses 1, so the difference could 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.

Caveats

These results apply to the people the trial enrolled: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley). 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.

256 enrolled.

HR 0.54 (0.36 to 0.81)

Download

95% CI 7.62 to 17.64; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.32 to 5.65

Source

HR 0.95 (0.64 to 1.39)

Download

95% CI 3.78 to 7.43; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.45 to 7.20

Source

HR 0.81 (0.55 to 1.21)

Download

95% CI 3.75 to 12.91; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication · 95% CI 3.48 to 7.20

Source

Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])

HR 0.69 (0.41 to 1.17)

Download

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + Sacituzumab Govitecan (SG)	74	11.17 months	0.54 (0.36 to 0.81)	-	link
	Avelumab + JB100 (NCT02603432)	74	3.75 months	0.54 (0.36 to 0.81)	-	link
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + M6223	72	5.42 months	0.95 (0.64 to 1.39)	-	link
	Avelumab + JB100 (NCT02603432)	74	4.5 months	0.95 (0.64 to 1.39)	-	link
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])primary	Avelumab + NKTR-255	73	5.59 months	0.81 (0.55 to 1.21)	-	link
	Avelumab + JB100 (NCT02603432)	74	4.5 months	0.81 (0.55 to 1.21)	-	link
Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])	Avelumab + Sacituzumab Govitecan (SG)	24	NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication	0.69 (0.41 to 1.17)	-	link
	Avelumab + JB100 (NCT02603432)	40	22.05 months	0.69 (0.41 to 1.17)	-	link

Connected

6top

Trial
Avelumab Program Rollover Study
Shares Avelumab, Merck KGaA (EMD Serono), Immune checkpoint inhibitors and the tag pipeline.
Trial
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Shares Avelumab, Muscle-invasive and advanced bladder cancer, Sacituzumab govitecan, Bladder & urothelial cancer and the tag pipeline.
Trial
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Immune checkpoint inhibitors and the tag pipeline.

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedMonoclonal antibody (anti-PD-L1)

Avelumab · Bavencio

ApprovedADC

Sacituzumab govitecan · Trodelvy

companies

Merck KGaA (EMD Serono)

Evidence strength46/100 · Emerging

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

Phase 2+15
256 enrolled+12
Primary endpoint: time to progression or recurrence+14
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 NCT05327530

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Overview

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Overview

Outcomes

Connected

Similar pages

cancers

technologies

drugs

companies